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.
RecruitingNAAn Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
HighLife SASMultiple US sitesmitral
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
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
Registry entry updated 2025-03-17
Active, not recruitingNACLASP IID/IIF
Edwards LifesciencesMultiple US sitesmitral
CLASP IID/IIF
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
- Who can join
- adult, older adult
- Participants
- 1247
- Expected completion
- 2031-06-30
- Funded by
- industry
Conditions studied
Degenerative Mitral Valve Disease, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Regurgitation
What it measures
- PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs)., 30 days.
- PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort., 6 months
- PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only., From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up
Registry entry updated 2026-07-08
RecruitingNAA Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
Sierra Valve LLCOne US sitemitral
A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
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
Registry entry updated 2026-04-24
Active, not recruitingNAA Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Boston Scientific CorporationMultiple US sitesmitral
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation
- Who can join
- adult, older adult
- Participants
- 4
- Expected completion
- 2026-11
- Funded by
- industry
Conditions studied
Cardiovascular Diseases, Mitral Regurgitation Functional, Mitral Valve Disease
What it measures
- Primary Safety Endpoint, The composite (aggregate) of the following implant-related and/or delivery-related serious adverse events (SAEs) at 30 days post index procedure (based on MVARC definitions and adjudicated by an independent clinical events committee). The unit of outcome measure is % (n/N): * Mortality: all-cause * Stroke: disabling and non-disabling; Bleeding: life-threatening based MVARC scale * Major access site vascular complications * Major cardiac structural complications due to access-related issues * Acute kidney injury (AKI; ≤7 days post index procedure): based on the Acute Kidney Injury Network (AKIN) --System Stage 3 (including renal replacement therapy) or Stage 2 * Myocardial infarction (MI; periprocedural \[≤48 hours\] or spontaneous \[\>48 hours\]) * Coronary ischemia requiring percutaneous coronary intervention (PCI) or coronary artery bypass graft * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention, 30 days post index procedure
- Primary Technical Success Endpoint, Technical Success (measured at exit from the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC ). All of the following must be present: Absence of procedural mortality; and Successful access, delivery and retrieval of the device delivery system; and Successful deployment and correct positioning of the first intended device; and Freedom from emergency surgery or reintervention related to the device or access procedure., Index procedure exit from the catheterization laboratory
Registry entry updated 2026-07-22
RecruitingNAAMEND TS Early Feasibility Study
Valcare Medical Ltd.Multiple US sitesmitral
AMEND TS Early Feasibility Study
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
Registry entry updated 2026-01-07
RecruitingNAATLAS
4C Medical Technologies, Inc.Multiple US sitesmitral
ATLAS
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.
Registry entry updated 2026-08-03
RecruitingNACephea Early Feasibility Study
Abbott Medical DevicesMultiple US sitesmitral
Cephea Early Feasibility Study
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
Registry entry updated 2026-09-11
Active, not recruitingNASUMMIT
Abbott Medical DevicesMultiple US sitesmitral
SUMMIT
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP). Subjects in the Randomized cohort were randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts were receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) was to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial would provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System would be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who were not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and were also not suitable for transcatheter repair with MitraClip, would be enrolled in the Non-repairable cohort. Subjects would be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.
- Who can join
- adult, older adult
- Participants
- 103
- Expected completion
- 2028-06
- Funded by
- industry
Conditions studied
Cardiovascular Diseases, Degenerative Mitral Valve Disease, Functional Mitral Regurgitation, Heart Valve Diseases, Mitral Insufficiency, Mitral Regurgitation, Mitral Valve Insufficiency, Valve Disease, Heart
What it measures
- Percentage of Participants With Freedom From All-cause Mortality and Heart Failure Hospitalization (HFH), The primary endpoint for the Severe MAC cohort is freedom from all-cause mortality and heart failure hospitalization (HFH), evaluated against a performance goal of 43%., 12 months post index procedure
Registry entry updated 2026-07-23
RecruitingNAEXPLORE-MRace
Polares Medical SAMultiple US sitesmitral
EXPLORE-MRace
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
Registry entry updated 2026-09-01
RecruitingNAEFS of the CardioMech MVRS
CardioMech ASMultiple US sitesmitral
EFS of the CardioMech MVRS
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
Registry entry updated 2026-02-10
RecruitingNAENHANCE EFS
Nyra Medical, Inc.Multiple US sitesmitral
ENHANCE EFS
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
Registry entry updated 2026-07-28
Active, not recruitingNAEdwards EVOQUE Eos MISCEND Study
Edwards LifesciencesMultiple US sitesmitral
Edwards EVOQUE Eos MISCEND Study
Edwards EVOQUE Eos MISCEND Study
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
- Who can join
- adult, older adult
- Participants
- 123
- Expected completion
- 2033-04-30
- Funded by
- industry
Conditions studied
Mitral Valve Regurgitation (Degenerative or Functional)
What it measures
- Composite of major adverse events, Proportion of patients with major adverse events, 30 days
Registry entry updated 2026-04-13
Active, not recruitingNAMitraClip REPAIR MR Study
Abbott Medical DevicesMultiple US sitesmitral
MitraClip REPAIR MR Study
MitraClip REPAIR MR Study
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.
- Who can join
- adult, older adult
- Participants
- 500
- Expected completion
- 2035-12
- Funded by
- industry
Conditions studied
Mitral Valve Regurgitation
What it measures
- All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded), The proportion of subjects who are alive, without stroke, CV hospitalization or acute kidney injury requiring renal replacement therapy at 2 years in the Device and Control groups, respectively, 2 Years
- Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous), Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) from the time of index procedure through 2 years in the Device and Control groups, respectively, 2 Years
Registry entry updated 2026-05-15
Active, not recruitingNAPRIMARY
Annetine GelijnsMultiple US sitesmitral
PRIMARY
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.
- Who can join
- adult, older adult
- Participants
- 450
- Expected completion
- 2034-01-01
- Funded by
- other
Conditions studied
Mitral Valve Regurgitation
What it measures
- All-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) composite score., All-cause mortality, valve re-intervention, hospitalizations/urgent visits for heart failure (without a blanking period), or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) from randomization to a minimum of 3 years post intervention. Composite score will be expressed as a Z-score - The Z-Score is a statistical measurement of a score's relationship to the mean in a group of scores. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher than the mean., 3 years post intervention
Working with
National Heart, Lung, and Blood Institute (NHLBI)
Registry entry updated 2026-09-10
RecruitingNACASSINI-US
InnovHeartMultiple US sitesmitral
CASSINI-US
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
Registry entry updated 2026-08-10
Active, not recruitingNASAPIEN M3 EFS
Edwards LifesciencesMultiple US sitesmitral
SAPIEN M3 EFS
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
- Who can join
- adult, older adult
- Participants
- 72
- Expected completion
- 2027-08-31
- Funded by
- industry
Conditions studied
Mitral Disease, Mitral Regurgitation
What it measures
- Technical Success, Defined as meeting all the following: * Alive * Successful access, delivery and retrieval of the delivery systems * Deployment of the devices in the intended position * Freedom from emergency surgery or reintervention related to the device or access procedure, At the end of the procedure
Registry entry updated 2026-07-17
RecruitingNATWIST-EFS
Edwards LifesciencesMultiple US sitesmitral
TWIST-EFS
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
Registry entry updated 2026-05-28
RecruitingNAENCIRCLE
Edwards LifesciencesMultiple US sitesmitral
ENCIRCLE
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
Registry entry updated 2026-02-25
RecruitingNAThe Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
Half Moon MedicalMultiple US sitesmitral
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
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
Registry entry updated 2024-01-12
RecruitingNAMITRAL-II
Mayra GuerreroMultiple US sitesmitral
MITRAL-II
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.
Registry entry updated 2026-01-13
RecruitingNAMINOS
Ottawa Heart Institute Research CorporationOne US sitemitral
MINOS
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
Registry entry updated 2026-05-06
Active, not recruitingNATranscatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
Medtronic CardiovascularMultiple US sitesmitral
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients. EFS: The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with moderate-Severe or severe, Symptomatic Mitral Regurgitation
- Who can join
- adult, older adult
- Participants
- 128
- Expected completion
- 2028-12
- Funded by
- industry
Conditions studied
Mitral Valve Insufficiency
What it measures
- Percent of Subjects With Adverse Events, PILOT: Site Reported Serious Adverse Events Implant or Delivery Related Through 30-Days EFS: Implant, Delivery or device related serious adverse events through 30 days post procedure, 30 days
Registry entry updated 2026-01-14
RecruitingNAAPOLLO
Medtronic CardiovascularMultiple US sitesmitral
APOLLO
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
Registry entry updated 2026-09-15
RecruitingNATRANSOM
Johns Hopkins UniversityOne US sitemitral
TRANSOM
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
Registry entry updated 2026-07-24
Active, not recruitingNARESTORE
Edwards LifesciencesMultiple US sitesmitral
RESTORE
Beating Heart Mitral Valve Repair With the HARPOON™ System
The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).
- Who can join
- adult, older adult
- Participants
- 25
- Expected completion
- 2027-12-20
- Funded by
- industry
Conditions studied
Mitral Regurgitation
What it measures
- Change in NYHA classification from Baseline to 5 years, The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest., Baseline compared to 1 and 5 years
Registry entry updated 2026-08-19
RecruitingCHOICE-MI
Universitätsklinikum Hamburg-EppendorfMultiple US sitesmitral
CHOICE-MI
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
Registry entry updated 2026-05-07
RecruitingENVISAGE
Montreal Heart InstituteOne US siteaorticmitraltricuspid
ENVISAGE
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
Registry entry updated 2025-10-09
Active, not recruitingNAImplantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip
samir kapadiaOne US sitemitral
Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip
Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip
This is an investigator initiated, prospective study to demonstrate the safety and feasibility of implantation of the V-Wave Interatrial Shunt System (herein called the "V-Wave Shunt" in patients immediately following percutaneous mitral valve repair using the MitraClip system.
- Who can join
- adult, older adult
- Participants
- 16
- Expected completion
- 2030-12-31
- Funded by
- other
Conditions studied
Heart Failure, Mitral Regurgitation
What it measures
- Number of Occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE), Number occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE) defined as: * All cause death * Stroke and paradoxical embolism * Myocardial infarction * V-Wave shunt device embolization * Cardiac tamponade * Device related re-intervention or surgery, Up to1 month post implant
Working with
V-Wave Ltd
Registry entry updated 2026-08-05