There may be more paths forward than you’ve been told.

Too many patients hear “there’s nothing more we can do” — and stop looking. That’s exactly the moment the HIP exists for.

Clinical trials test treatments that aren’t available anywhere else yet — often for patients who don’t qualify for anything else. Even if a second or third opinion has left you without treatment options, you can ask your care team whether a clinical trial may be relevant.

Eligibility depends on your diagnosis, history, and location — the HIP team or your cardiologist can help you figure out if you qualify.

First, what is a clinical trial?

A clinical trial is a carefully supervised study of a treatment that is not yet available to everyone. It is not an experiment done to you. You are looked after by a full medical team, usually more closely than in ordinary care, and you can stop taking part at any point, for any reason.

Every trial has rules about who can join, based on your diagnosis, your history, and sometimes your age or where you live. That is why some people qualify and others do not. Taking part is free of charge for the treatment being studied.

For valve conditions that do not yet have an approved option, or for people who have been turned away everywhere else, a trial is sometimes the way to reach a treatment years before it is widely available.

Why We Keep This List

We keep track of these studies so you do not have to search through medical databases on your own.

RecruitingNA

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Edwards LifesciencesMultiple US sites
aortic

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Who can join
child, adult, older adult
Participants
1234
Expected completion
2037-01
Funded by
industry

Conditions studied

Aortic Stenosis, Severe

What it measures

  • Non-hierarchical composite of death and stroke, The number of patients that died or had a stroke, 1 year
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-09-03

RecruitingNA

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

HighLife SASMultiple US sites
mitral

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.

Who can join
adult, older adult
Participants
30
Expected completion
2030-12
Funded by
industry

Conditions studied

Mitral Regurgitation

What it measures

  • Continued intended performance of the HighLife™ bioprosthesis, defined as the reduction of mitral regurgitation (MR) to either optimal (0+ to trace) or acceptable (reduced by at least 1 grade from baseline with no more than 2+ MR) without significant mitral stenosis (post-procedure EOA ≥ 1.5 cm2 with a transmitral gradient \< 5mmHg) and with no greater than mild (1+) paravalvular MR (and without associated hemolysis), at 30 days post procedure
  • Freedom of major adverse events, including: * All-cause mortality * Myocardial infarction or coronary ischemia requiring PCI or CABG * Major stroke * Life-threatening bleeding (MVARC scale) * Major access and vascular complications * Stage 2 or 3 acute kidney injury (includes dialysis) * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention * Severe hypotension, heart failure or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for ≥ 48H, at 30 days post procedure
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2025-03-17

RecruitingNA

TRIVITA

VDyne, Inc.One US site
tricuspid

VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)

Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.

Who can join
adult, older adult
Participants
730
Expected completion
2036-06
Funded by
industry

Conditions studied

Cardiovascular Diseases (CVD), Heart Valve Diseases, Randomized Controlled Trial (RCT), Severe Heart Valve Disease, Symptomatic Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency, Tricuspid Valve Regurgitation

What it measures

  • Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ), The Quality of Life KCCQ questionnaire is a measure of health-related quality of life. It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure. From 23-items, the Overall Summary Score (OSS) will be calculated. In the OSS, each of the 23 items are converted onto a 0 to 100 scale using this formula: (Raw score - Minimum Raw Score)/(Maximum Raw Score - Minimum Raw Score) \* 100. Then these are averaged across the 23 items. A score of 100 (the maximum score) would indicate maximum quality of life relating to heart failure and a score of 0 (scale minimum) would indicate the worst possible quality of life relating to heart failure, with higher scores generally indicating higher quality of life., 12 months post procedure
  • Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA), The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure by classifying patients in one of four categories based on their limitations during physical activity and in degree of shortness of breath and or angina pain. Class I is the least severe and Class IV is the most severe. The classes are: Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients., 12 months post procedure
  • Composite of all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention, All-cause mortality, heart failure hospitalization and non-elective tricuspid valve reintervention will be adjudicated by a Clinical Events Committee., 12 months post-procedure
  • Composite of major adverse events (MAEs), Composite of major adverse events consist of the following: * Cardiovascular mortality * Stroke * Life-threatening bleeding * Major vascular complications * Major cardiac structural complications * Stage 2 or 3 acute kidney injury * Myocardial infarction or coronary ischemia * Device-related obstruction of forward flow * Device-related pulmonary embolism * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention, 30 days post-procedure
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-08-17

RecruitingNA

A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.

Sierra Valve LLCOne US site
mitral

A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.

To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.

Who can join
adult, older adult
Participants
15
Expected completion
2031-05-31
Funded by
industry

Conditions studied

Mitral Regurgitation

What it measures

  • Effectiveness: Acute procedural success (APS), APS is defined as the successful implantation of the GeminiOne device and achieving residual MR of 2+ or less at discharge. lf the discharge echocardiogram is unavailable or difficult to interpret, an echocardiogram taken at 30 days can be used instead. A death before discharge or a reoperation of the mitral valve within 30 days is considered an acute procedural failure., 30 days
  • Safety: Absence of device or procedure related major adverse events at 30 days, MAE is defined as the occurrence of any of the following within 30 days: death, myocardial infarction (Ml) stroke, MVARC-defined Grade 3 Acute Kidney Injury (AKl), major access site and vascular complications, major cardiac structural complications or cardiac surgery due to GeminiOne device failure., 30 days
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-04-24

Recruiting

TREAT TR

Abbott Medical DevicesMultiple US sites
tricuspid

A Post-Market Assessment of the Safety and Performance of the TriClip™ System

The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved indications for use.

Who can join
adult, older adult
Participants
1000
Expected completion
2033-08
Funded by
industry

Conditions studied

Tricuspid Regurgitation (TR)

What it measures

  • Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points, All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status., At 30-day follow-up
  • Rate of Peri-Procedural Adverse Events, Defined as all-cause mortality, device embolization, device thrombosis, non-elective surgery or transcatheter intervention for device- or procedure-related adverse event (AE) new pacemaker implantation and device- or procedure related major bleeding, Through 30 days post-procedure
  • Tricuspid Regurgitation (TR) grade less than or equal to moderate, At 30-day follow-up
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-09-02

RecruitingNA

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Edwards LifesciencesMultiple US sites
aortic

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Who can join
child, adult, older adult
Participants
200
Expected completion
2039-12
Funded by
industry

Conditions studied

Aortic Valve Insufficiency, Aortic Valve Stenosis

What it measures

  • Non-hierarchical composite of death and stroke, The number of patients that died or had a stroke, 1 year
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-07-27

RecruitingNA

AMEND TS Early Feasibility Study

Valcare Medical Ltd.Multiple US sites
mitral

AMEND TS Early Feasibility Study

Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments.

Who can join
adult, older adult
Participants
15
Expected completion
2027-04
Funded by
industry

Conditions studied

Symptomatic Functional MR 3 or Greater

What it measures

  • Safety Endpoint: Composite of death (all-cause), stroke, myocardial infarction (MI), or non-elective cardiovascular surgery for device related complications at 30 days., The definitions of the SAEs are based on the recommendation of the Mitral Valve Academic Research Consortium (MVARC) (Stone, 2015)., 30 days
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-01-07

RecruitingNA

ARTIST

JenaValve Technology, Inc.Multiple US sites
aortic

ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™

To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)

Who can join
child, adult, older adult
Participants
1016
Expected completion
2036-02
Funded by
industry

Conditions studied

Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Insufficiency

What it measures

  • All stroke, Number of patients that had stroke, 12 months
  • All-Cause Mortality, all-cause mortality at 12 months, 12 months
  • unplanned cardiac rehospitalization, Number of patients who had unplanned cardiac rehospitalization, 12 months
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-09-17

RecruitingNA

ATLAS

4C Medical Technologies, Inc.Multiple US sites
mitral

ATLAS (AltaValve) Pivotal Trial

This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.

Who can join
adult, older adult
Participants
450
Expected completion
2031-09
Funded by
industry

Conditions studied

Mitral Incompetence, Mitral Insufficiency, Mitral Regurgitation, Mitral Valve Incompetence, Mitral Valve Regurgitation

What it measures

  • Composite of all-cause mortality or heart failure hospitalization., 12 months.
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-08-03

RecruitingNA

BELIEVE-IT

Cedars-Sinai Medical CenterOne US site
aortic

Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial

The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). Namely, the therapies to which patients will be randomized will be transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), in patients deemed clinically suitable for both following heart team review. The purpose of this study is to compare the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) versus Surgical Aortic Valve Replacement (SAVR) for treating patients with severe aortic stenosis (AS) who have a congenital bicuspid aortic valve (BAV) anatomy. Patients with BAV anatomy have been under-represented in previous trials and this study might provide important information to help guide future treatment options. The study patients will be followed with standard of care procedures for 10 years.

Who can join
adult, older adult
Participants
250
Expected completion
2037-02-01
Funded by
other

Conditions studied

Aortic Valve Stenosis, Bicuspid Aortic Valve

What it measures

  • 1 year hierarchical composite outcome of death, disabling stroke, non-disabling stroke, valve reintervention, rehospitalization, unfavorable KCCQ (VARC 3), The primary endpoint will be analyzed by the Win ratio method14. That is, every patient in the TAVR group will be compared with every patient in the SAVR group to determine which pair has won. A win higher up in the hierarchy takes priority, so KCCQ gets used only for those pairs that were tied on the first 5 event components. Then KCCQ win is declared if the time-averaged change in KCCQ differs by 5 points or more. The win ratio= total wins on TAVR divided by total wins on SAVR, for which a 95% CI and p value is calculated., 1 year
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2025-02-10

Recruiting

Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

Cedars-Sinai Medical CenterOne US site
aortic

Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

The objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.

Who can join
adult, older adult
Participants
2000
Expected completion
2028-08-15
Funded by
other

Conditions studied

Bicuspid Aortic Valve

What it measures

  • Death, Death from any cause, 1 month
  • Death, Death from any cause, 1 year
  • Death, Death from any cause, 2 years
  • Death, Death from any cause, 3 years
  • Death, Death from any cause, 4 years
  • Death, Death from any cause, 5 years
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2019-02-11

RecruitingNA

CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material

EmStop IncMultiple US sites
aortic

CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material

The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.

Who can join
adult, older adult
Participants
663
Expected completion
2028-05
Funded by
industry

Conditions studied

Aortic Stenosis, Aortic Valve Disease, Aortic Valve Stenosis

What it measures

  • Non-Inferiority, Primary combined safety and efficacy endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30-days, Non-inferiority of 30-day EmStop device MACCE patient incidence rate compared to the Sentinel device patient incidence rate

Working with

Bright Research Partners

Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-08-26

RecruitingNA

COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Edwards LifesciencesMultiple US sites
pulmonary

COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Who can join
child, adult, older adult
Participants
108
Expected completion
2031-06
Funded by
industry

Conditions studied

Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Degeneration, Pulmonary Valve Insufficiency

What it measures

  • THV dysfunction, Defined as a non-hierarchical composite of: RVOT reintervention, Moderate or greater total pulmonary regurgitation (PR) via Transthoracic Echocardiography (TTE), Mean RVOT gradient \> 40 mmHg via TTE, 1 year
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-07-23

RecruitingNA

Cephea Early Feasibility Study

Abbott Medical DevicesMultiple US sites
mitral

Cephea Early Feasibility Study

The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.

Who can join
adult, older adult
Participants
90
Expected completion
2031-03-01
Funded by
industry

Conditions studied

Mitral Regurgitation

What it measures

  • Primary Effectiveness Endpoint, Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant., 30 days post implant
  • Primary Safety Endpoint, Freedom from all-cause mortality, which will be assessed at 30 days post implant., 30 days post implant
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-09-11

RecruitingNA

VISTA-US

VDyne, Inc.Multiple US sites
tricuspid

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)

The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).

Who can join
adult, older adult
Participants
30
Expected completion
2031-11-30
Funded by
industry

Conditions studied

Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders

What it measures

  • Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs, Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs, Baseline to 1 month after implant
  • Changes in functional capacity (6-minute walk test), Changes in functional capacity (6-minute walk test), Baseline to 1 month after implant
  • Changes in in quality of life (KCCQ score), Changes in in quality of life (KCCQ score). A higher score indicates worsening quality of life outcomes, Baseline to 1 month after implant
  • Changes in symptom status (NYHA class), Changes in symptom status (NYHA class), Baseline to 1 month after implant
  • The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC)., The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC)., Implant to 30 days post-procedure
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-03-31

RecruitingNA

Clinical Study of the inQB8 TTVR System (The MonarQ Study)

inQB8 Medical Technologies, LLCMultiple US sites
tricuspid

Clinical Study of the inQB8 TTVR System (The MonarQ Study)

Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.

Who can join
adult, older adult
Participants
50
Expected completion
2030-10-31
Funded by
industry

Conditions studied

Tricuspid Valve Regurgitation

What it measures

  • Absence of device or procedure related major adverse events, 30 days
  • Change in TR grade from baseline, 30 days
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-05-18

RecruitingNA

EXPLORE-MRace

Polares Medical SAMultiple US sites
mitral

EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)

The goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation. It will also learn about the safety of the device MR-ace Implant and Delivery System. The main questions it aims to answer are: Does implanting the MR-ace device reduce the symptoms of mitral regurgitation? Does the device reduce the the leak through your mitral valve? Participants will: Be implanted with the device Visit the clinic for checkups and tests at 30 days, 6 months, 12 months, and 2, 3, 4 and 5 years following your procedure Complete a quality of life survey

Who can join
adult, older adult
Participants
15
Expected completion
2032-12-31
Funded by
industry

Conditions studied

Mitral Regurgitation

What it measures

  • Primary Performance Endpoint, Reduction in mitral regurgitation (Grade 2+ or less) as evaluated by 2D transthoracic echocardiography., 30 days post procedure
  • Primary Safety Endpoint, All-cause mortality, 30 days post procedure
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-09-01

RecruitingNA

EFS of the CardioMech MVRS

CardioMech ASMultiple US sites
mitral

EFS of the CardioMech MVRS

Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.

Who can join
adult, older adult
Participants
25
Expected completion
2031-09
Funded by
industry

Conditions studied

Mitral Regurgitation

What it measures

  • Change in MR grade, 30 days
  • Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure, 30 days
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-02-10

RecruitingNA

TANDEM II

CroiValve LimitedMultiple US sites
tricuspid

EFS of the DUO System for Tricuspid Regurgitation

The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).

Who can join
adult, older adult
Participants
15
Expected completion
2029-10
Funded by
industry

Conditions studied

Heart Valve Diseases, Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency

What it measures

  • Freedom from device or procedure related MAEs, * Death * Reintervention * Disabling stroke * Myocardial infarction * Major access site and vascular complications * Severe bleeding * Renal failure requiring dialysis * Major cardiac structural complications * Pulmonary embolism, At 30 days
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-06-01

RecruitingNA

ENVISION

Abbott Medical DevicesMultiple US sites
aortic

ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation

The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. The trial will also evaluate the safety and effectiveness of the Navitor TAVI System in a valve-in-valve (ViV) application in patients with symptomatic heart disease due to failure of a surgical or transcatheter bioprosthetic aortic valve who are at high or greater surgical risk. In addition, the trial will assess the safety of the Navitor TAVI System for the treatment of symptomatic, severe native aortic stenosis in patients with bicuspid aortic valve anatomy, irrespective of surgical risk classification.

Who can join
adult, older adult
Participants
1500
Expected completion
2036-04
Funded by
industry

Conditions studied

Aortic Valve Disease, Aortic Valve Stenosis, Heart Disease Structural Disorder, Heart Valve Diseases

What it measures

  • Composite of all-cause mortality or all stroke, Number of patients that had any of the outcome events., At 12 months post-procedure
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-09-11

RecruitingNA

Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Laplace Interventional, IncMultiple US sites
tricuspid

Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Who can join
adult, older adult
Participants
65
Expected completion
2032-12
Funded by
industry

Conditions studied

Tricuspid Regurgitation

What it measures

  • Technical success, Successful valve implantation, During procedure
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-07-23

RecruitingNA

ENHANCE EFS

Nyra Medical, Inc.Multiple US sites
mitral

Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System

Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.

Who can join
adult, older adult
Participants
30
Expected completion
2032-12
Funded by
industry

Conditions studied

Mitral Regurgitation Functional

What it measures

  • Primary Endpoint, Freedom from device- or procedure-related serious adverse events through 30-days post-procedure, 30-days post-procedure
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-07-28

RecruitingNA

Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

Cardiac Implants LLCMultiple US sites
tricuspid

Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following implantation in patients suffering from ≥ moderate functional tricuspid regurgitation (FTR).

Who can join
adult, older adult
Participants
15
Expected completion
2027-09
Funded by
industry

Conditions studied

Tricuspid Regurgitation Functional

What it measures

  • Freedom from device or procedure-related mortality, Freedom from mortality determined to be primarily caused by the device or procedure in the primary endpoint cohort. Events adjudicated by a Clinical Events Committee (CEC)., 30 days post-adjustment
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2021-11-30

RecruitingNA

CLASP II TR

Edwards LifesciencesMultiple US sites
tricuspid

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Who can join
adult, older adult
Participants
1270
Expected completion
2031-12-31
Funded by
industry

Conditions studied

Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency

What it measures

  • Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score), Comparison of number of participants with composite endpoint events between experimental and active comparator arms, 6 months
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-09-14

Recruiting

TRIPLACE

Montefiore Medical CenterMultiple US sites
tricuspid

Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the timing and onset of conduction disturbances necessitating permanent pacemaker implantation, and how such patients are managed. On this background, the TRIPLACE Registry - an investigator-initiated global multicenter registry - is aimed at better understanding the safety and efficacy of orthotopic TTVR.

Who can join
adult, older adult
Participants
800
Expected completion
2028-12
Funded by
other

Conditions studied

Tricuspid Regurgitation

What it measures

  • Freedom from device-related complications, Freedom from device-related complications will be determined by assessing the number of participants with procedural, peri-procedural and device-related complications, 30 days after the index procedure
  • Reduction in Tricuspid Regurgitation Severity, Tricuspid Regurgitation measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Tricuspid Regurgitation is measured by transthoracic echocardiography in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Change from baseline tricuspid regurgitation severity score 30 days after baseline will be assessed, 30 days after the index procedure

Working with

The Cleveland Clinic, University Hospital, Bordeaux, University of Toronto

Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-09-15

RecruitingNA

Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Innoventric LTDMultiple US sites
tricuspid

Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).

Who can join
adult, older adult
Participants
15
Expected completion
2030-08
Funded by
industry

Conditions studied

Tricuspid Regurgitation, Tricuspid Regurgitation Functional

What it measures

  • Rate of Major Adverse Events [Safety endpoint], Rate of device or procedure-related Major Adverse Events (MAEs) And Rate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure, at the end of the procedure, at discharge - typically within a week, and 30 days
  • Technical Performance, Successful access, delivery, and retrieval of the Trillium™ delivery system, device is anchored both in SVC and IVC \[at the end of the procedure\] And No need for re-intervention due to device valve regurgitation or para-stent leak \[at discharge, and 30 days\], at the end of the procedure, at discharge - typically within a week, and 30 days

Working with

Innoventric Inc.

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Data Sources and Methodology

Registry entry updated 2025-03-07

Recruiting

ILIT

Baylor Research InstituteOne US site
aortic

Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g. trans-carotid)

Who can join
adult, older adult
Participants
50
Expected completion
2027-10-01
Funded by
other

Conditions studied

Aortic Valve Stenosis, Iliac Disease

What it measures

  • Acute technical success per the DISRUPT PAD definition at the time of intervention, Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion, At time of IVL procedure
  • Success rate of transfemoral delivery of a TAVR system post IVL within 30 days of treatment, To know the efficacy of the treatment, At the time of TAVR procedure

Working with

Shockwave Medical, Inc.

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Data Sources and Methodology

Registry entry updated 2026-08-21

RecruitingNA

JOURNEY

JC Medical, Inc., an affiliate of Edwards Lifesciences LLCMultiple US sites
aortic

J-Valve Transfemoral Pivotal Study

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.

Who can join
adult, older adult
Participants
194
Expected completion
2032-02
Funded by
industry

Conditions studied

Aortic Valve Disease Mixed, Aortic Valve Regurgitation

What it measures

  • All-cause mortality at 1 year, 1-year post-procedure
  • The composite rate of early-safety outcomes at 30 days as defined by the Valve Academic Research Consortium 3 (VARC-3), Includes: * All-cause death * All stroke * VARC-3 type 2-4 bleeding * Major vascular, access-related, or cardiac structural complication * Acute kidney injury (AKI) stage 3 or 4 * New permanent pacemaker due to procedure-related conduction abnormalities * Surgery or intervention related to the device, 30-days post-procedure

Working with

Cardiovascular Research Foundation, New York, Minneapolis Heart Institute Foundation

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Data Sources and Methodology

Registry entry updated 2026-05-04

RecruitingNA

MRI-TAVR

University Hospitals Cleveland Medical CenterOne US site
aortic

MRI in Transcatheter Aortic Valve Replacement Patients

The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV. Furthermore, the hypothesis is that stress CMR will be able to demonstrate differences in these hemodynamic parameters. CMR will also provide refined assessment of paravalvular leak and its impact on ventricular function and on clinical outcomes.

Who can join
adult, older adult
Participants
90
Expected completion
2026-12-30
Funded by
other

Conditions studied

Aortic Valve Stenosis

What it measures

  • Effective orifice area (EOA), Change in effective orifice area (EOA) assessed by CMR between baseline and 1-year follow up (cm2), Baseline, 30-days and 1-year
  • Mean gradient, Mean AV gradient assessed by CMR (mmHg), 1-year
  • Peak gradient, Mean AV gradient assessed by CMR (mmHg), 1-year
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Data Sources and Methodology

Registry entry updated 2025-12-17

RecruitingNA

PARTNER 3 Trial - Aortic Valve-in-Valve

Edwards LifesciencesMultiple US sites
aortic

PARTNER 3 Trial - Aortic Valve-in-Valve

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Who can join
child, adult, older adult
Participants
125
Expected completion
2038-04
Funded by
industry

Conditions studied

Aortic Stenosis, Aortic Stenosis, Severe

What it measures

  • Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke, Number of patients that died and/or had a stroke, 1 year
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Data Sources and Methodology

Registry entry updated 2024-05-10

RecruitingNA

PROGRESS

Edwards LifesciencesMultiple US sites
aortic

PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Who can join
older adult
Participants
2250
Expected completion
2037-06
Funded by
industry

Conditions studied

Aortic Stenosis, Calcific, Aortic Valve Stenosis

What it measures

  • Primary Effectiveness Endpoint, Non-hierarchical composite of death, and heart failure hospitalization or event, 2 years
  • Primary Safety Endpoint, Non-hierarchical composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complication, and valve dysfunction requiring reintervention, 30 days
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2025-12-17

RecruitingNA

Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)

Jenscare Innovation Inc.Multiple US sites
tricuspid

Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)

The goal of this clinical trial is to learn if LuX-Valve Plus system works to treat symptomatic subjects with at least severe tricuspid regurgitation (TR). It will also learn about the safety of LuX-Valve Plus system. Researchers will compare LuX-Valve Plus system to a conventional device called EVOQUE to see if LuX-Valve Plus system works to treat subjects with at least severe tricuspid regurgitation. Participants will: Undergo one procedure using the LuX-Valve Plus system or EVOQUE after passing screening and enrolling in the trial; Complete follow-up visits and examinations as required by the trial protocol; Report any adverse events

Who can join
adult, older adult
Participants
680
Expected completion
2038-12
Funded by
industry

Conditions studied

Tricuspid Regurgitation (TR)

What it measures

  • Rate of Composite Clinical Success, Percentage (%) of participants achieving composite clinical success at 12 months. Composite clinical success is defined as meeting all of the following criteria: Patient survival, Free from heart failure hospitalization, No tricuspid valve surgery or percutaneous intervention, 12 Months Post-Procedure
  • Rate of Major Adverse Events (MAE), Rate of Major Adverse Events (MAE) at 30 days consisting of the following components: * Cardiovascular Mortality * Myocardial Infarction (MI), periprocedural and spontaneous * All Stroke, disabling and non-disabling * New need for renal replacement therapy * Severe bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\] * Non-elective tricuspid valve re-intervention, surgery or transcatheter * Major access site and vascular complications * Major cardiac structural complications * Device-related pulmonary embolism * Arrhythmia and conduction disorders requiring permanent pacing, 30 Day Post-Procedure
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Data Sources and Methodology

Registry entry updated 2026-08-28

Recruiting

PROTECT-TAVR

Atlantic Health SystemMultiple US sites
aortic

Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR

The goal of this clinical trial is to evaluate the feasibility, effectiveness, and safety of pre-emptive left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in patients undergoing complex and high-risk transcatheter aortic valve replacement (TAVR). These patients include adults with severe aortic stenosis who are hemodynamically unstable or at risk of instability due to anatomical complexity. The main questions it aims to answer are: 1. Does pre-emptive LAVA-ECMO reduce the incidence of in-hospital death, intraprocedural cardiac arrest, or emergent cardiac surgery? 2. What are the safety outcomes related to LAVA-ECMO, including major vascular, bleeding, or cardiac structural complications? -This is a single-arm, prospective, multi-center study with no comparison group. Participants will: * Be screened for eligibility based on hemodynamic status and anatomical complexity * Undergo pre-emptive LAVA-ECMO cannulation prior to or during TAVR * Receive follow-up assessments at 30 days and 1 year, including clinical evaluation and echocardiography

Who can join
adult, older adult
Participants
30
Expected completion
2027-06-30
Funded by
other

Conditions studied

Cardiogenic Shock, Cardiogenic Shock, ECMO, Severe Aortic Stenosis, Trans-catheter Aortic Valve Implantation

What it measures

  • Primary Efficacy Endpoint: Composite of in-hospital death, intraprocedural resuscitated cardiac arrest or emergent cardiac surgery., From enrollment through hospital discharge (up to 30 days post-procedure)
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Data Sources and Methodology

Registry entry updated 2025-12-30

Recruiting

RESTORE

Medtronic CardiovascularMultiple US sites
aortic

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).

Who can join
adult, older adult
Participants
225
Expected completion
2027-11
Funded by
industry

Conditions studied

Aortic Stenosis

What it measures

  • Primary Outcome Measure, 30-day redo TAVR success defined as correct positioning of a single redo prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index (DVI) ≥0.25, aortic regurgitation (AR) \< moderate), and freedom from all-cause mortality, coronary obstruction, unplanned coronary revascularization, and surgery or intervention related to the device, Early (30-days)
  • Primary Outcome Measure, a composite endpoint of 1-year freedom from all-cause mortality, all stroke, or any re-hospitalization for valve or redo TAVR procedure-related causes, Late (1-year)
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Data Sources and Methodology

Registry entry updated 2026-05-28

RecruitingNA

CASSINI-US

InnovHeartMultiple US sites
mitral

Reduction or Elimination of Mitral Regurgitation With the SATURN TMVR System (CASSINI-US)

CASSINI-US is a prospective, single-arm, multicenter early feasibility study enrolling up to 15 patients at up to 5 sites in the United States (US). The purpose of the study is to evaluate the technical (implant) feasibility, and safety, and performance of the SATURN TS TMVR System for the treatment of moderate-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. Primary objectives evaluate the implant feasibility, and acute safety and performance of the SATURN TS TMVR System. The secondary objective and additional outcome measures characterize the long-term safety and performance of the SATURN TS TMVR System.

Who can join
adult, older adult
Participants
15
Expected completion
2032-09
Funded by
industry

Conditions studied

Heart Disease, Mitral Regurgitation

What it measures

  • Freedom from Major Adverse Events Endpoint, Freedom from (n/N, %) device-related or procedure-related major adverse events (MAE) which include: Cardiovascular death, Peri-procedural myocardial infarction, Disabling stroke, Major cardiac structural complication, Major vascular complication, and Mitral reintervention (operative or transcatheter) due to progressive or recurrent MR or device-related complications., 30 days from index procedure
  • Mitral Valve Effectiveness Endpoint (reduction in MR grade), Defined as the reduction of mitral regurgitation Grade to ≤1+ at 30 days., 30 days post treatment
  • Technical (Implant) Success Endpoint, Presented as the n/N (%) of patients that meet the definition of Implant Success per protocol., At completion of study procedure (Day 0)

Working with

Avania

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Data Sources and Methodology

Registry entry updated 2026-08-10

RecruitingNA

STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)

MiRusOne US site
aortic

STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)

To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.

Who can join
adult, older adult
Participants
1025
Expected completion
2028-04
Funded by
industry

Conditions studied

Aortic Stenosis, Symptomatic Severe Native Aortic Stenosis

What it measures

  • All-cause mortality, all stroke and cardiovascular rehospitalization, The primary endpoint is the composite of all-cause mortality, all stroke, and cardiovascular rehospitalization (valve-related or procedure-related per VARC-3) at 1 year., 1 Year
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Data Sources and Methodology

Registry entry updated 2026-04-09

Recruiting

TVTR

The Society of Thoracic SurgeonsMultiple US sites
aortic

STS/ACC Transcatheter Valve Therapy Registry (TVT Registry)

The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter aortic valve replacement (TAVR) procedure. Created by The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT Registry is designed to monitor the safety and efficacy of this new procedure for the treatment of aortic stenosis.

Who can join
adult, older adult
Participants
16000
Expected completion
2035-06
Funded by
other

Conditions studied

Aortic Valve Stenosis

What it measures

  • Major adverse cardiac and cerebrovascular events, increase in the 30-day risk of adverse events among patients receiving TAVR, 30 day

Working with

American College of Cardiology

Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2022-08-25

RecruitingNA

BELIEVERS

Cedars-Sinai Medical CenterOne US site
aortic

TAVR vs SAVR in Severe Bicuspid Aortic Stenosis

The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). The two primary comparators in this study are: Transcatheter Aortic Valve Replacement (TAVR), and Surgical Aortic Valve Replacement (SAVR). TAVR is a minimally invasive transcatheter procedure to treat aortic valve disease.. SAVR is involving the open chest surgery to replace the aortic valve. The devices and international procedures in this Trial (TAVR or SAVR) are commercially approved by the FDA. Consented patients who are qualifying for the Trial will be randomized 1:1, meaning they will have an equal chance to be treated with either TAVR or SAVR procedure. Consented patients who will not qualify for the randomized part of the study will be followed up clinically in either TAVR or SAVR Registry arms. The study objective is to provide evidence to guide patients and their providers on the most appropriate therapy for valve replacement on this particular BAV anatomy.

Who can join
adult, older adult
Participants
1200
Expected completion
2040-05-10
Funded by
other

Conditions studied

Bicuspid Aortic Valve Disease

What it measures

  • To compare the safety and effectiveness of TAVR vs SAVR for the treatment of severe AS in patients with BAV, A hierarchical composite (assessed by Win ratio at latest available follow-up) of: 1. death, 2. disabling stroke, 3. non-disabling stroke, 4. valve reintervention, 5. rehospitalization†, 6. unfavorable KCCQ (VARC-3\*), 2 years post end of enrollment

Working with

Icahn School of Medicine at Mount Sinai, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Patient-Centered Outcomes Research Institute

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Data Sources and Methodology

Registry entry updated 2026-08-14

RecruitingNA

TWIST-EFS

Edwards LifesciencesMultiple US sites
mitral

TVMR With the INNOVALVE System Trial - Early Feasibility Study

Study to evaluate the safety and performance of the INNOVALVE system

Who can join
adult, older adult
Participants
65
Expected completion
2031-07-01
Funded by
industry

Conditions studied

Mitral Valve Regurgitation (Degenerative or Functional)

What it measures

  • Absence of implant or delivery related serious adverse events at 30 Days, Absence of implant or delivery related serious adverse events, 30 days
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Data Sources and Methodology

Registry entry updated 2026-05-28

RecruitingNA

ENCIRCLE

Edwards LifesciencesMultiple US sites
mitral

The ENCIRCLE Trial

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Who can join
adult, older adult
Participants
900
Expected completion
2031-02-28
Funded by
industry

Conditions studied

Mitral Regurgitation, Mitral Valve Insufficiency

What it measures

  • Non-hierarchical composite of death and heart failure rehospitalization, Number of subjects with death and/or heart failure rehospitalization, 1 year
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Data Sources and Methodology

Registry entry updated 2026-02-25

RecruitingNA

The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study

Half Moon MedicalMultiple US sites
mitral

The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study

The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.

Who can join
adult, older adult
Participants
30
Expected completion
2029-12-31
Funded by
industry

Conditions studied

Mitral Valve Insufficiency

What it measures

  • Adverse Events, Evaluation of the nature, severity and frequency of complications associated with the delivery and/or implantation of the device, 30 Days
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Data Sources and Methodology

Registry entry updated 2024-01-12

RecruitingNA

MITRAL-II

Mayra GuerreroMultiple US sites
mitral

The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).

A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥ moderate stenosis and ≥ regurgitation). There are 2 Arms in this study: 1) "Transseptal (TS) Valve-in-MAC" (ViMAC) Arm, and 2) Natural History of Disease Registry (NHDR) for patients treated with medical treatment only (which includes patients who meet inclusion criteria but can't be treated with transeptal ViMAC due to the presence of anatomical exclusion criteria or other exclusion criteria) and have not had other procedures that may impact outcomes (i.e., alcohol septal ablation or radiofrequency ablation). The study also includes a Registry of Permanently Unassigned" for subjects who undergo preemptive septal ablation procedures (alcohol or radiofrequency) in anticipation of continuing onto ViMAC arm, but are not accepted in the ViMAC Study arm or the patient chooses not to undergo ViMAC procedure.

Who can join
adult, older adult
Participants
210
Expected completion
2030-12
Funded by
other

Conditions studied

Mitral Annular Calcification, Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease

What it measures

  • Primary Safety Endpoint: All Cause Morality and Hospitalization for Heart Failure, A non-hierarchical composite of all-cause mortality and hospitalization for heart failure., 1 year.
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Data Sources and Methodology

Registry entry updated 2026-01-13

RecruitingNA

TRICURE EFS

TRiCaresMultiple US sites
tricuspid

The TRICURE EFS Study

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Who can join
adult, older adult
Participants
15
Expected completion
2031-03
Funded by
industry

Conditions studied

Cardiovascular Diseases, Heart Valve Diseases, Tricuspid Valve Regurgitation

What it measures

  • Composite of MAE, Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications., 30 day post-intervention
  • Device Success, Device success defined as a reduction in tricuspid regurgitation immediately post-intervention, immediately post-intervention
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-07-23

RecruitingNA

MINOS

Ottawa Heart Institute Research CorporationOne US site
mitral

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

Mitral regurgitation may be seen in the setting of cardiogenic shock. Transcatheter edge-to-edge repair (TEER) has been shown to improve outcomes in patients with chronic heart failure. Observational studies suggest improvements in clinical outcomes in patients with mitral regurgitation in the setting of cardiogenic shock; however, there remains a lack of randomized clinical data to support the use of TEER in cardiogenic shock. This study will be a multicenter, open-label, randomized-controlled trial with two study arms: medical therapy and TEER. Patients admitted to the Cardiac Intensive Care Unit (CICU), Cardiac Surgery Intensive Care Unit (CSICU) or Intensive Care Units (ICU) at participating centers will be recruited. The study aims to answer the question: "Does TEER in patients with SCAI stage C or D cardiogenic with concomitant moderate or greater mitral regurgitation improve outcomes as compared to medical therapy?" The study hypothesis is that TEER will lead to an overall improvement in the composite outcome as compared to the medical therapy arm.

Who can join
adult, older adult
Participants
144
Expected completion
2028-05
Funded by
other

Conditions studied

Cardiogenic Shock, Mitral Regurgitation

What it measures

  • Primary composite outcome, The primary outcome in this clinical trial will be a composite of in-hospital all-cause mortality, cardiac transplantation, implantation of durable LVAD, or discharge on palliative inotropic therapy., Through duration of hospitalization, generally up to 12 weeks following admission
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Data Sources and Methodology

Registry entry updated 2026-05-06

RecruitingNA

APOLLO

Medtronic CardiovascularMultiple US sites
mitral

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

Who can join
adult, older adult
Participants
1056
Expected completion
2036-07-07
Funded by
industry

Conditions studied

Mitral Valve Regurgitation

What it measures

  • MAC Cohort, All-cause mortality, 1 year
  • Primary Cohort, Composite of all-cause mortality or heart failure hospitalization, 1 year
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Data Sources and Methodology

Registry entry updated 2026-09-15

RecruitingNA

PATHFINDER

Medtronic CardiovascularMultiple US sites
tricuspid

Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation

This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.

Who can join
adult, older adult
Participants
1186
Expected completion
2041-04
Funded by
industry

Conditions studied

Severe Tricuspid Regurgitation

What it measures

  • Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention, 1-year post-procedure
  • Rate of Major Adverse Events (MAE), 30-days post-procedure
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-07-28

RecruitingNA

TRANSOM

Johns Hopkins UniversityOne US site
mitral

Transventricular Off-pump Mitral Valve Repair

The purpose of this study is to assess the safety and effectiveness (usefulness) of an investigational technique used to repair the mitral valve for patients with mitral regurgitation due to a defective valve leaflet. This procedure is called trans-ventricular off-pump mitral valve repair (TRANSOM) and it repairs the mitral valve by replacing some of the cords that support the mitral valve. This type of repair is minimally-invasive since it is performed through a small incision and avoids making a breast-bone-splitting incision.

Who can join
adult, older adult
Participants
175
Expected completion
2029-07-01
Funded by
other

Conditions studied

Mitral Valve (MV) Regurgitation

What it measures

  • Primary Effectiveness Endpoint: Composite Freedom from Death, Recurrent mitral regurgitation (MR), and Re-intervention, Freedom from all-cause mortality, recurrent moderate or severe mitral regurgitation, and re-intervention on the mitral valve., 1 year post-index procedure.
  • Primary Safety Endpoint: Composite Freedom from Major Adverse Events, Freedom from a composite of major adverse events including all-cause mortality, all stroke, acute kidney injury (AKI), major bleeding, new permanent pacemaker implantation, deep sternal wound infection (DSWI) or access site infection requiring surgical intervention, and prolonged mechanical ventilation., 30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-07-24

RecruitingNA

SHIELD

EnCompass Technologies, Inc.Multiple US sites
aortic

Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)

Who can join
adult, older adult
Participants
500
Expected completion
2027-01
Funded by
industry

Conditions studied

Aortic Diseases, Aortic Stenosis Treated With TAVI

What it measures

  • Major Adverse Cardiac and Cerebrovascular Events (MACCE), MACCE includes the composite of death, all stroke, acute kidney injury (AKI) stage 3 or 4 within 7 days post-index procedure Valve Academic Research Consortium 3 (VARC-3) and any major vascular complication (VARC-3), 30 days post procedure
  • Total New Lesion Volume, Total new lesion volume (TNLV) in the brain assessed by diffusion weighted magnetic resonance images (DW-MRI), 8-72 hours post procedure

Working with

Avania, Insight Medical Consulting

Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2025-11-20

RecruitingNA

Trisol System EFS Study

Trisol MedicalMultiple US sites
tricuspid

Trisol System EFS Study

The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).

Who can join
adult, older adult
Participants
30
Expected completion
2031-07-01
Funded by
industry

Conditions studied

Tricuspid Regurgitation

What it measures

  • Change in TR from baseline, Change in TR from baseline: reduction in TR grade immediately following implantation as compared to baseline TR grade, based on TEE imaging., During procedure
  • Rate of device-related serious adverse events, Rate of device-related serious adverse events, including death (cardiovascular and non- cardiovascular), MI (MVARC definitions), disabling stroke, life-threatening bleeding (MVARC type III-V), renal failure requiring dialysis, emergency surgery, need for additional surgical procedures due to device failure, Up to 30 days
  • Rate of procedural success, Procedural success: freedom from emergency surgery or reintervention related to the device or access procedure, without death, stroke, or device dysfunction, Up to 30 days
  • Rate of technical success, Technical success: delivery and deployment of the device in the correct position and retrieval of the delivery system., During procedure
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Data Sources and Methodology

Registry entry updated 2025-11-21

RecruitingNA

PROTEUS

Venus MedTech (HangZhou) Inc.Multiple US sites
pulmonary

VenusP-Valve Pivotal Study (PROTEUS STUDY)

A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction. Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years. About 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval.

Who can join
child, adult, older adult
Participants
60
Expected completion
2034-08-30
Funded by
industry

Conditions studied

Pulmonary Regurgitation

What it measures

  • The rate of procedure or device related mortality at the 30 days follow-up visit post procedure, Freedom from procedure or device related mortality at 30 days, At 30 Days Post Procedure
  • The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit post procedure, Freedom from VenusP-Valve re-intervention and acceptable hemodynamic function at 6 months defined as: 1. No more than mild regurgitation measured by CMR; AND 2. Mean RVOT gradient as measured by echocardiography ≤35mmHg., At 6 Months Post Procedure
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Data Sources and Methodology

Registry entry updated 2025-02-28

Recruiting

TTVR-AHI

Columbia UniversityMultiple US sites
tricuspid

Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study

TTVR-AHI is a multicenter, retrospective registry including heart failure patients displaying a severe and symptomatic tricuspid regurgitation (TR), deemed non-eligible to cardiac surgery and therefore treated with transcatheter tricuspid valve replacement (TTVR) devices. This substudy of the main registry will focus on those with post-procedural acute hemodynamic instability (AHI).

Who can join
adult, older adult
Participants
140
Expected completion
2029-05-01
Funded by
other

Conditions studied

Heart Failure, Interventional Cardiology, Structural Heart Disease, Tricuspid Regurgitation

What it measures

  • Mortality Rate, The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group., 1 Year
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Data Sources and Methodology

Registry entry updated 2026-02-12

Recruiting

CHOICE-MI

Universitätsklinikum Hamburg-EppendorfMultiple US sites
mitral

CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR). The registry primarily focuses on patients treated with TMVR in real-world clinical practice. Patients evaluated for TMVR but not undergoing the procedure are no longer systematically included. Historical data may include such patients who subsequently underwent alternative treatments, including transcatheter edge-to-edge repair, mitral valve surgery, or medical/conservative therapy.

Who can join
adult, older adult
Participants
1000
Expected completion
2030-12-31
Funded by
other

Conditions studied

Mitral Annular Calcification, Mitral Regurgitation, Mitral Valve Disease

What it measures

  • Freedom from device-related complications, 30 days
  • Mitral insufficiency grade 2+ or more, Mitral insufficiency measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease., 12 months

Working with

Montreal Heart Institute, University Hospital, Bordeaux

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Data Sources and Methodology

Registry entry updated 2026-05-07

RecruitingPHASE4

CT TAVR

University of Maryland, BaltimoreOne US site
aortic

CT TAVR Abdomen Study

A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or doses. Reducing iodinated IV contrast dose can mitigate IV contrast supply shortages and enable significant cost savings for the radiology practice and hospital system. In addition, decreased IV contrast dose can potentially reduce the rate of acute kidney injury, specifically in patients with decreased renal function. The purpose of the study is to determine whether low IV contrast dose CT with monoenergetic reconstruction can be use for presurgical planning of transcatheter valve replacement (TAVR) procedure.

Who can join
adult, older adult
Participants
164
Expected completion
2028-03-01
Funded by
other

Conditions studied

Transcatheter Aortic Valve Replacement

What it measures

  • Diagnostic Quality of Images, 5-point Likert Scale, 18-24 months
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Data Sources and Methodology

Registry entry updated 2026-07-01

Recruiting

ENVISAGE

Montreal Heart InstituteOne US site
aorticmitraltricuspid

Enhanced Valves Interventions and Safe AI Generated End Results

This non-interventional study aims to use artificial intelligence to improve the prediction of transcatheter heart valve interventions and optimize patient outcomes. It is based on the analysis of retrospective data from various specialized centers worldwide.

Who can join
adult, older adult
Participants
21000
Expected completion
2029-05
Funded by
other

Conditions studied

Heart Valve Disease, M-TEER, Mitraclip, T-TEER, TAVI, TMVI, TTVI, TriClip

What it measures

  • Accuracy of transcatheter AI predictions, Validation of artificial intelligence algorithms for automatic segmentation of anatomic structures and imaging measurements, and prediction of the success of transcatheter interventions. Output of AI algorithm: * Sizes, types, and number of devices to be implanted * Device success * Percentage risk of permanent pacemaker implantation (for TAVI and TTVI) * Percentage risk of 30-day (para)valvular regurgitation for TAVI, and residual regurgitation for M-TEER and T-TEER * Single leaflet detachment for M-TEER and T-TEER * Left ventricular outflow tract obstruction for TMVI. Key success indicators: * First, independent retrospective validation dataset AI algorithms predict procedural outcome with \>90% accuracy and low inter-reader observer variability when compared to measured procedural outcome. * Second independent retrospective dataset, perform a study to validate AI algorithms with \>90% accuracy and low inter-reader observer variability when compared to measured procedural outcome., Preoperative phase: automated segmentation and measurements compared with manual assessments; Postoperative phase at day 30: comparison of predicted results with actual clinical patient outcomes.

Working with

Centre Cardiologique du Nord, Centre Hospitalier Universitaire de Bordeaux, FRANCE, Clinique Pasteur Toulouse, Hospitaux Universitaires Paris Sud, Istituto clinico Città di Brescia, Materialise, Montefiore Medical Center, Pie Medical Imaging, Rennes University Hospital, San Raffaele University Hospital, Italy, Unity Health Toronto, University Hospital, Lille, University Hospital, Marseille, University Medical Center Mainz, Universitätsklinikum Hamburg-Eppendorf, Vancouver Hospital

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Data Sources and Methodology

Registry entry updated 2025-10-09

RecruitingNA

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

Mauro H. SchenoneOne US site
aortic

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS).

Who can join
female, child, adult
Participants
80
Expected completion
2036-07
Funded by
other

Conditions studied

Hypoplastic Left Heart Syndrome

What it measures

  • Number cases with pulmonary hypertension, Baseline
  • Number of cases in which a biventricular repair was achieved, Baseline
  • Number of cases in which the procedure was successful, Procedure success defined as the aortic valve was crossed and the balloon inflated with clear evidence of improvement of blood flow through the aortic valve and or new aortic valve regurgitation, Baseline
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Data Sources and Methodology

Registry entry updated 2026-05-01