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New heart valve implant offers hope for patients too sick for surgery

NCT ID NCT03433274

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tests a new device called Tendyne, which is a replacement heart valve placed through a tube in the blood vessels, avoiding open-heart surgery. It is for people with a leaky mitral valve (mitral regurgitation) who are too high-risk for traditional surgery. The trial compares Tendyne to another device (MitraClip) and also tests it in people with severe calcium buildup in the valve. The goal is to see if the device can reduce deaths and hospital stays related to heart failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

103 people

The number who actually took part.

Started

Jun 2018

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Symptomatic, moderate-to-severe or severe mitral regurgitation (MR ≥ Grade III per American Society of Echocardiography criteria), or severe mitral annular calcification (MAC), where a transcatheter therapy is deemed more appropriate than open surgery by the local site heart team. Note: MR and MS severity must be determined by assessment of a qualifying transesophageal echocardiogram (TEE) and transthoracic echocardiogram (TTE), obtained within 120 days prior to subject consent, and must be confirmed by the Echocardiography Core Laboratory. Note: Patients with severe MAC must have symptomatic mitral valve disease associated with MR≥ Grade III, or severe mitral stenosis (MS), or both moderate MR and moderate MS as assessed by the Echocardiography Core Laboratory. 2. NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory). 3. The local site heart team determines that the subject has been adequately treated per applicable standards for coronary artery disease (e.g., revascularization), left ventricular dysfunction (e.g., cardiac resynchronization therapy) and heart failure (e.g., GDMT). The SEC must concur that the subject has been adequately treated. 4. The local site heart team and the SEC concur on the intended study cohort for the subject. Randomized cohort: Eligibility for this cohort is limited to subjects where the local site heart team deems the mitral valve anatomy is suitable for TEER and are within approved Mitra Clip indications, which must be confirmed by experienced Mitra Clip operators within the SEC. Subjects with primary MR must be at prohibitive surgical risk, while subjects with secondary MR must be symptomatic despite maximally-tolerated guideline-directed medical therapy and meet the Mitra Clip Indications for Use. Non-repairable cohort: Eligibility for this cohort is limited to subjects where the local site heart team deems the mitral valve anatomy is not suitable for TEER with Mitra Clip or does not meet Mitra Clip indications, which must be confirmed by experienced Mitra Clip operators from the SEC. Severe MAC cohort: Eligibility for this cohort is limited to subjects where the local site heart team deems the degree of MAC renders the subject unsuitable for mitral valve surgery. Severe MAC CAP cohort: Eligibility for this cohort is identical to the original Severe MAC cohort. 5. Age 18 years or older at time of consent. 6. Subject has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group, complying with trial required testing, medications, and follow-up visits, and has provided written informed consent. Exclusion Criteria: 1. Mitral valvular vegetation or mass. 2. Left Ventricle or Left Atrium thrombus. 3. Chest condition that prevents transapical access. 4. LVEF less than 25% assessed by the site based on a TTE obtained within 120 days prior to subject consent. Note: LVEF will be principally based on TTE and confirmed by the Echocardiography Core Laboratory. 5. LVEDD \> 7.0 cm assessed by the site based on a TTE obtained within 120 days prior to subject consent. Note: A qualifying LVEDD must be confirmed by the Echocardiography Core Laboratory. 6. Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material (e.g. valve repair or replacement, or Mitra Clip). 7. Mitral pathoanatomy and LVOT anatomy deemed not suitable for Tendyne transcatheter mitral valve implantation. 8. Aortic valve disease requiring surgery or transcatheter intervention. 9. Tricuspid valve disease requiring surgery or transcatheter intervention. 10. Severe tricuspid regurgitation or severe right ventricular dysfunction. 11. Any surgical or interventional procedure within the period of 60 days prior to or planned procedure 60 days following subject registration. 12. Implant or revision of CRT device within 90 days prior to intended subject registration. 13. Myocardial infarction within 30 days prior to intended subject registration. 14. Symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease (e.g., active ischemia) requiring stenting or CABG. 15. CVA within 6 months prior to intended subject registration. 16. Unresolved severe symptomatic carotid stenosis (\> 70% by ultrasound). 17. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure. 18. Hypertrophic or restrictive cardiomyopathy, or constrictive pericarditis. 19. Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated. 20. History of endocarditis within 6 months of planned implant procedure. 21. Active systemic infection requiring antibiotic therapy. 22. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anti-coagulation or antiplatelet therapy) that cannot be adequately managed medically. 23. Subjects in whom TEE is contraindicated or high risk. 24. Known hypersensitivity to nickel or titanium. 25. Subject is undergoing hemodialysis due to chronic renal failure. 26. Subject has pulmonary arterial hypertension (fixed PAS \>70mmHg). Note: If PAS \> 70mmHg, site must provide documentation PAS is not fixed in order to be eligible. 27. Subject has COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use. 28. Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months. 29. Modified Rankin Scale ≥ 4 disability. 30. Status 1 heart transplant or prior orthotopic heart transplantation. 31. Pregnant, lactating, or planning pregnancy during the clinical investigation follow-up period. Note: Female subjects of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release). 32. Currently participating in an investigational drug or another device trial that has not reached its primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. 33. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart valve disorder mitral valve disorder mitral valve insufficiency mitral valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Degenerative mitral valve disease Functional mitral regurgitation Heart valve diseases Mitral insufficiency Mitral regurgitation Mitral valve insufficiency Valve disease, heart

Contacts and locations

Locations

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Adventist HealthCare White Oak Medical Center

    Silver Spring, Maryland, 20904, United States

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453, United States

  • Albany Medical College at Albany Medical Center

    Albany, New York, 12208, United States

  • Allegheny General Hospital - ASRI

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension Saint Thomas

    Nashville, Tennessee, 37205, United States

  • Ascension St. Vincent

    Indianapolis, Indiana, 46260, United States

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67226, United States

  • Atrium Health - Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Banner-University Medical Center

    Phoenix, Arizona, 85006, United States

  • Baptist Health Medical Center

    Little Rock, Arkansas, 72205, United States

  • Baptist Hospital of Miami

    Miami, Florida, 33176, United States

  • Baptist Medical Center Princeton

    Birmingham, Alabama, 35211, United States

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120, United States

  • BayCare Healthcare System - Morton Plant Hospital

    Clearwater, Florida, 33756, United States

  • Baylor Scott & White The Heart Hospital - Dallas

    Dallas, Texas, 75226, United States

  • Buffalo General Medical Center

    Buffalo, New York, 14203, United States

  • Catholic Medical Center

    Manchester, New Hampshire, 03102, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Delray Medical Center

    Delray Beach, Florida, 33484, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Fresno Heart Hospital

    Fresno, California, 93720, United States

  • HCA Florida North Florida Hospital

    Gainesville, Florida, 32605, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Institut de Cardiologie de Montreal (Montreal Heart Institute)

    Montreal, Quebec, H1T 1C8, Canada

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360, United States

  • MUHC - The Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1, Canada

  • Manatee Memorial Hospital

    Bradenton, Florida, 34208, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • MedStar Union Memorial Hospital

    Balitmore, Maryland, 21218, United States

  • Medical City Dallas Hospital

    Dallas, Texas, 75230, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mission Health

    Asheville, North Carolina, 28801, United States

  • New York Presbyterian Hospital/Cornell University

    New York, New York, 10065, United States

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112, United States

  • Northwell Health - South Shore University Hospital

    Bay Shore, New York, 11706, United States

  • Novant Health Heart and Vascular Research Institute

    Charlotte, North Carolina, 28204, United States

  • Oklahoma Heart Institute at Utica

    Tulsa, Oklahoma, 74104, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Prairie Education & Research Cooperative

    Springfield, Illinois, 62701, United States

  • Providence Heart & Vascular Institute

    Portland, Oregon, 97225, United States

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • San Diego Cardiac Center

    San Diego, California, 92123, United States

  • Scottsdale Healthcare Shea

    Scottsdale, Arizona, 85258, United States

  • St. Alphonsus Regional Medical Center

    Boise, Idaho, 83706, United States

  • St. David's Healthcare Office of Research

    Austin, Texas, 78756, United States

  • St. Louis University Hospital

    St Louis, Missouri, 63110, United States

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • Stanford Health Care

    Stanford, California, 94305, United States

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Sutter Medical Center, Sacramento

    Sacramento, California, 95816, United States

  • Swedish Medical Center - Heart & Vascular

    Seattle, Washington, 98122, United States

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The International Heart Institute of Montana

    Missoula, Montana, 59802, United States

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • UAB University Hospital

    Birmingham, Alabama, 35233, United States

  • UPMC Shadyside

    Pittsburgh, Pennsylvania, 15232, United States

  • UTHealth Memorial Hermann

    Houston, Texas, 77030, United States

  • University of California - Davis Medical Center

    Sacramento, California, 95817, United States

  • University of California at San Francisco

    San Francisco, California, 94143, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109, United States

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • University of Southern California University Hospital

    Los Angeles, California, 90033, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

  • Wellstar Kennestone Regional Medical Center

    Marietta, Georgia, 30060, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.