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.

Active, not recruitingNA

ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement

Boston Scientific CorporationMultiple US sites
aortic

ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement

To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR. As of 28-May-2025, Boston Scientific Corporation (BSC) announced the voluntary global discontinuation of the ACURATE product platform, including both the ACURATE neo2 and ACURATE Prime Aortic Valve Systems. BSC will no longer pursue regulatory approval for the device in the U.S. or other unapproved geographies.

Who can join
child, adult, older adult
Participants
1948
Expected completion
2029-09
Funded by
industry

Conditions studied

Aortic Stenosis

What it measures

  • Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort., Primary Endpoint: A Clinical Events Committee (CEC), independent group of physician experts reviewed and adjudicated all reported cases of death, stroke and rehospitalization to determine whether they met the specific protocol definition of the event. The CEC adjudicated results are used in the endpoint analysis. \* Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); per VARC-2 definition., Participants will be followed for the duration of hospital stay through 1 year.
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-09-16

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

Active, not recruitingNA

Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

Emblok, Inc.Multiple US sites
aortic

Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with a commercially available embolic protection device. The targeted study population consists of patients meeting FDA-approved indications for TAVR with commercially available transcatheter heart valve systems. This prospective, multicenter, single-blind, randomized controlled trial will enroll up to a total of 532 subjects undergoing TAVR at up to 30 investigational sites in the United States. All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days.

Who can join
adult, older adult
Participants
532
Expected completion
2025-10-01
Funded by
industry

Conditions studied

Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Replacement, Aortic Valve Stenosis

What it measures

  • Debris capture, defined as the average number of captured particles ≥150 µm in diameter, as assessed by independent histologic analysis, The co-primary filtration efficacy endpoint is debris capture, defined as the average number of captured particles ≥150 μm in diameter, as assessed by independent histologic analysis., Evaluated at the time of the TAVR procedure (during the intervention/procedure)
  • Incidence of the composite of all-cause mortality, all stroke (disabling or non-disabling) and transient ischemic attack (TIA), and Acute Kidney Injury Stage 2 or 3 (including renal replacement therapy), according to VARC-2 definitions, The primary safety and efficacy endpoint is combined safety and efficacy at 30 days, defined as a composite of the following VARC-2 defined components: * All-cause mortality * All stroke (disabling or non-disabling) and transient ischemic attack (TIA) * Acute Kidney Injury Stage 2 or 3 (including renal replacement therapy), Evaluated at 30-day post-procedure (TAVR) follow-up visit

Working with

Yale Cardiovascular Research Group

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

Registry entry updated 2025-08-06

Active, not recruitingNA

Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

Medtronic CardiovascularMultiple US sites
aortic

Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR

Who can join
adult, older adult
Participants
150
Expected completion
2030-12
Funded by
industry

Conditions studied

Bicuspid Aortic Valve

What it measures

  • Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure., Device success rate, defined as: * Absence of procedural mortality, AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days), 7 days
  • Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure., Rate of of all-cause mortality or disabling stroke rate at 30 days, 30 days
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-05-05

Active, not recruitingNA

SURTAVI

Medtronic CardiovascularMultiple US sites
aortic

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

Who can join
child, adult, older adult
Participants
1746
Expected completion
2026-11
Funded by
industry

Conditions studied

Severe Aortic Stenosis

What it measures

  • All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability, All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline., 24 months
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-06-24

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

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

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

Active, not recruitingNA

EARLY TAVR

Edwards LifesciencesMultiple US sites
aortic

EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.

Who can join
older adult
Participants
901
Expected completion
2032-03
Funded by
industry

Conditions studied

Aortic Stenosis, Severe, Heart Diseases

What it measures

  • All-cause death, all stroke, and unplanned cardiovascular hospitalization, The number of patients that have any of these conditions, When all patients have reached 2-year follow-up
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2024-05-13

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

Active, not recruitingNA

Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis

Abbott Medical DevicesMultiple US sites
aortic

Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis

The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.

Who can join
adult, older adult
Participants
11
Expected completion
2031-06
Funded by
industry

Conditions studied

Symptomatic Severe Aortic Stenosis

What it measures

  • Device success, Intended performance of the valve, 30 days
  • Technical success, Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system., From start of procedure up to end of procedure
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-02-06

Active, not recruitingNA

Early Feasibility Study for the Foldax Tria Aortic Heart Valve

Foldax, IncMultiple US sites
aortic

Early Feasibility Study for the Foldax Tria Aortic Heart Valve

The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.

Who can join
adult, older adult
Participants
40
Expected completion
2026-12
Funded by
industry

Conditions studied

Aortic Valve Disease, Aortic Valve Stenosis

What it measures

  • Primary Effectiveness Endpoint: Hemodynamic Performance Assessment, Hemodynamic performance parameters are mmHG mean gradient and derived Effective Orifice Area (EOA). Success is defined as clinically significant improvement in hemodynamic performance (Effective Orifice Area (EOA)) at one year based on literature reports for surgical aortic valve replacement., 12 months following patient enrollment completion
  • Primary Effectiveness Endpoint: New York Heart Association Improvement Assessment, Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification status at 365 days compared to baseline. a. Class I - No symptoms and no limitations in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. b. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. c. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. d. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients., 12 months following patient enrollment completion
  • Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments, The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard. a. Thromboembolism b. Valve Thrombosis c. Major Paravalvular leak d. Major Hemorrhage e. Endocarditis, 12 months following patient enrollment completion
  • Primary Safety Endpoints: Surgical Valve Events Rate Assessment, The rates of other events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature. a. All-caused death b. Valve related death c. Valve-related reoperation d. Valve explant e. Hemorrhage f. All-cause reoperation g. Valve-related death, 12 months following patient enrollment completion
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2023-09-13

Active, not recruitingNA

Evolut™ EXPAND TAVR II Pivotal Trial

Medtronic CardiovascularMultiple US sites
aortic

Evolut™ EXPAND TAVR II Pivotal Trial

Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.

Who can join
older adult
Participants
650
Expected completion
2034-12
Funded by
industry

Conditions studied

Moderate Aortic Valve Stenosis

What it measures

  • Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention., Life threatening or fatal bleeding is defined as BARC Type 3 or 4 and acute kidney injury is defined as VARC-3 Stage IV., 30 days
  • Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention., 2 years
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-05-19

Active, not recruitingNA

ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis

Edwards LifesciencesMultiple US sites
aortic

ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis

This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).

Who can join
child, adult, older adult
Participants
101
Expected completion
2030-07
Funded by
industry

Conditions studied

Aortic Valve Stenosis

What it measures

  • All-cause Death, Number of participants that died, 1 year
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2025-11-13

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.

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

Registry entry updated 2026-08-21

Active, not recruitingNA

JVTF EFS

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

J-Valve TF Early Feasibility Study

The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.

Who can join
child, adult, older adult
Participants
25
Expected completion
2029-08-25
Funded by
industry

Conditions studied

Aortic Regurgitation, Aortic Valve Disease, Aortic Valve Insufficiency

What it measures

  • Number of patients that do not experience death or disabling stroke, Freedom from death or disabling stroke Disabling stroke is evaluated using a standardized scale, 30 days after the valve procedure
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2025-07-11

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

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

Registry entry updated 2025-12-17

Active, not recruitingNA

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

Medtronic CardiovascularMultiple US sites
aortic

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

Who can join
child, adult, older adult
Participants
2223
Expected completion
2029-06
Funded by
industry

Conditions studied

Aortic Valve Stenosis

What it measures

  • Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study, Assessment of procedural safety by: All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling stroke: a modified rankin score (mRS) of 2 or more at 90 days post-stroke and an increase of at least one mRS category from an individual's pre-stroke baseline. All stroke: any stroke after valve intervention (ischemic, hemorrhagic, or undetermined stroke)., Randomized Controlled Trial - 24 months Continued Access Study - 12 months
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-05-07

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

Registry entry updated 2024-05-10

Active, not recruitingNA

P3

Edwards LifesciencesMultiple US sites
aortic

PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.

Who can join
child, adult, older adult
Participants
1000
Expected completion
2029-12
Funded by
industry

Conditions studied

Aortic Stenosis

What it measures

  • All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure), Number of patients that had any of these events, 1 year
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-01-14

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

Active, not recruitingNA

Portico Next Generation Approval Study

Abbott Medical DevicesMultiple US sites
aortic

Portico Next Generation Approval Study

The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the rate of moderate or greater paravalvular leak at 30 days in a high or extreme surgical risk patient population to support CE (Conformité Européenne) Mark and FDA approval.

Who can join
adult, older adult
Participants
333
Expected completion
2033-01
Funded by
industry

Conditions studied

Symptomatic Severe Aortic Stenosis

What it measures

  • Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak, Number of participants with moderate or greater paravalvular leak at 30 days., at 30 days
  • Primary Safety Endpoint is All-cause Mortality, All-cause mortality is defined as the total number of deaths in each cohort at 30 days., at 30 days
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-07-21

Active, not recruitingNA

PORTICO-IDE

Abbott Medical DevicesMultiple US sites
aortic

Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic aortic stenosis via transfemoral and alternative delivery methods in high risk and extreme risk patients.

Who can join
adult, older adult
Participants
1242
Expected completion
2026-12
Funded by
industry

Conditions studied

Aortic Valve Stenosis

What it measures

  • Percentage of Patients With Major Vascular Complications (Primary Safety Endpoint- FlexNav Delivery System Study), Valve Academic Research Consortium (VARC) 2- defined major vascular complications, 30 days from index procedure
  • Primary Effectiveness Endpoint (Randomized IDE Cohort), A composite of all-cause mortality or disabling stroke at one year., One-year from randomization
  • Primary Safety Endpoint (Randomized IDE Cohort), Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days., 30 days from randomization
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2025-07-20

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

Registry entry updated 2026-05-28

Active, not recruitingNA

SMART

Medtronic CardiovascularMultiple US sites
aortic

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. Additionally, a stress echocardiography sub-study will be conducted as part of the SMART Trial at select sites. The purpose of the sub-study is to evaluate performance of SE versus BE TAVR in subjects with a small aortic annulus and symptomatic severe native aortic stenosis after undergoing exercise stress echocardiographic testing.

Who can join
adult, older adult
Participants
1103
Expected completion
2027-12
Funded by
industry

Conditions studied

Aortic Valve Replacement, Aortic Valve Stenosis, Symptomatic Aortic Stenosis

What it measures

  • Bioprosthetic Valve Dysfunction (BVD), Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve)), 12 months
  • Mortality, Disabling Stroke or Heart Failure Rehospitalization, Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization., 12 months
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-06-02

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
Read more about this studyOpen the study listing and contact the team
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

Active, not recruitingNA

Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study

MiRusMultiple US sites
aortic

Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study

The Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.

Who can join
adult, older adult
Participants
30
Expected completion
2025-12
Funded by
industry

Conditions studied

Aortic Stenosis Symptomatic

What it measures

  • All-cause mortality or disabling stroke, Mortality will be reported as rate of death/mortality at 30 days. Disabling stroke will be reported according to Valve Academic Research Consortium (VARC-3) Guidelines, 30 Days
  • Technical success of implantation of the Siegel TAVR, Technical success will be reported as freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device., Immediate post procedure
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2025-12-03

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

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

Registry entry updated 2026-08-14

Active, not recruitingNA

THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study

JenaValve Technology, Inc.Multiple US sites
aortic

THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study

To collect information about treatment for severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.

Who can join
adult, older adult
Participants
100
Expected completion
2027-09-29
Funded by
industry

Conditions studied

Aortic Regurgitation

What it measures

  • All-Cause Mortality at 30 days, All-Cause mortality within the first 30 days post index procedure, 30 days
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2022-11-18

Active, not recruitingNA

JENA-VAD

JenaValve Technology, Inc.Multiple US sites
aortic

The JenaValve ALIGN-AR LVAD Registry

To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR

Who can join
adult, older adult
Participants
50
Expected completion
2027-08
Funded by
industry

Conditions studied

Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Disease, Aortic Valve Insufficiency, Left Ventricular Dysfunction

What it measures

  • Acute Kidney Injury, Number of patients that had acute kidney injury (AKI) stage 3 or 4, 30 days
  • All Stroke, Number of patients that had stroke, 30 days
  • All-cause mortality, All-cause mortality within the first 30 days post index procedure, 30 days
  • Bleeding, Freedom from VARC type 2-4 bleeding, 30 days
  • Device Performance, Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)\*, 30 days
  • Device Positioning, Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location, 30 days
  • Device Success, Freedom from unsuccessful delivery of the device, and retrieval of the delivery system, 30 days
  • Major Vascular Complication, Number of patients that had major vascular, access-related, or cardiac structural complication, 30 days
  • Permanent pacemaker implantation, Number of patients that had these events, 30 days
  • Surgery/intervention related to device, Freedom from surgery or intervention related to the device# or to a major vascular or access-related or cardiac structural complication, 30 days
  • Total aortic regurgitation, Number of patients that had moderate or severe total aortic regurgitation, 30 days
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-07-22

Active, not recruitingNA

ALIGN-AR

JenaValve Technology, Inc.Multiple US sites
aortic

The JenaValve ALIGN-AR Pivotal Trial

To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.

Who can join
adult, older adult
Participants
180
Expected completion
2028-08
Funded by
industry

Conditions studied

Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Disease, Aortic Valve Insufficiency

What it measures

  • Acute Kidney Injury, Number of patients that had these events, 30 days
  • All Stroke, Number of patients that had a stroke, 30 days
  • All-Cause Mortality at 1 Year, All-cause mortality within the first 12 months post index procedure, 1 year
  • Major Bleeding, Number of patients that had any of these events, 30 days
  • Major Vascular Complications, Number of patients that had these events, 30 days
  • Permanent pacemaker implantation, Number of patients that had these events, 30 days
  • Surgery/intervention related to the device, Number of patients that had these events, 30 days
  • Total aortic regurgitation, Number of patients that had these events, 30 days
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2022-09-13

Active, not recruitingNA

Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

Cardiovascular Research Foundation, New YorkMultiple US sites
aortic

Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.

Who can join
adult, older adult
Participants
178
Expected completion
2025-02
Funded by
other

Conditions studied

Aortic Valve Stenosis

What it measures

  • All-Cause Death, Hierarchical occurrence within efficacy assessment time interval (EATI) of:, 12 months
  • Change in KCCQ relative to baseline, Hierarchical occurrence within efficacy assessment time interval (EATI) of:, 12 months
  • Disabling Stroke, Hierarchical occurrence within efficacy assessment time interval (EATI) of:, 12 months
  • Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke -or - Clinically significant worsening of heart failure (heart failure hospitalization equivalent)., Hierarchical occurrence within efficacy assessment time interval (EATI) of:, 12 months

Working with

Avania, Cardialysis BV

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

Registry entry updated 2024-11-27

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

Active, not recruitingNA

DurAVR™ EFS

Anteris Technologies Ltd.Multiple US sites
aortic

Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study

To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.

Who can join
older adult
Participants
15
Expected completion
2033-12
Funded by
industry

Conditions studied

Aortic Stenosis, Aortic Valve Calcification, Severe Aortic Valve Stenosis, Symptomatic Aortic Stenosis

What it measures

  • All-cause mortality or disabling stroke, Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines, 30days
  • Technical success, Freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device., Immediate post procedure
Read more about this studyOpen the study listing and contact the team
Data Sources and Methodology

Registry entry updated 2026-06-26

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
Read more about this studyOpen the study listing and contact the team
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

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

Registry entry updated 2026-05-01