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

NCT ID NCT03242642

Disease control Sponsor: Medtronic Cardiovascular Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 6 times

Summary

This study tests a new device to replace the mitral valve in people with severe mitral regurgitation (a leaky heart valve) who cannot have standard surgery or a less invasive repair. About 1,056 participants will receive the device and be followed for safety and quality of life. The goal is to see if the device can control the disease and improve symptoms.

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

About 1,056 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2017

Expected to finish

Jul 2036

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: * Moderate to severe or severe symptomatic mitral regurgitation * Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention Exclusion Criteria: * prior transcatheter mitral valve procedure with device currently implanted * anatomic contraindications * prohibitive mitral annular calcification * left ventricular ejection fraction \<25% * need for emergent or urgent surgery * hemodynamic instability

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart disorder heart valve disorder mitral valve insufficiency

As listed by the trial registrant

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

Mitral valve regurgitation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    75 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abbott Northwestern Hospital

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Abrazo Heart Hospital

    RECRUITING

    Phoenix, Arizona, 85018, United States

  • Aurora St. Luke's Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Baptist Medical Center Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Barnes-Jewish Hospital

    RECRUITING

    St Louis, Missouri, 63110-1003, United States

  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital

    WITHDRAWN

    Dallas, Texas, 75246, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CHI Saint Luke's Health-Baylor Saint Luke's Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Carilion Roanoke Memorial Hospital

    ACTIVE_NOT_RECRUITING

    Roanoke, Virginia, 24014, United States

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Corewell Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Duke University Medical Center

    WITHDRAWN

    Durham, North Carolina, 27710, United States

  • El Camino Hospital

    RECRUITING

    Mountain View, California, 94040, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Glen Royal Victoria Hospital

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • HealthPark Medical Center

    RECRUITING

    Fort Myers, Florida, 33908, United States

  • Heart Hospital of Austin

    RECRUITING

    Austin, Texas, 78756, United States

  • Henry Ford Saint John Hospital

    RECRUITING

    Detroit, Michigan, 48236, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Inova Fairfax Hospital

    RECRUITING

    Fairfax, Virginia, 22042, United States

  • Integris Baptist Medical Center

    RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • JFK Medical Center

    RECRUITING

    Atlantis, Florida, 33462, United States

  • Jersey Shore University Medical Center

    RECRUITING

    Neptune City, New Jersey, 07753, United States

  • Kaiser Permanente Los Angeles Medical Center

    RECRUITING

    Los Angeles, California, 90027, United States

  • Kaiser Permanente San Francisco Medical Center

    RECRUITING

    San Francisco, California, 94118-3100, United States

  • Keck Hospital of the University of Southern California, USC

    RECRUITING

    Los Angeles, California, 90033, United States

  • Lankenau Medical Center

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • Los Robles Regional Medical Center

    RECRUITING

    Thousand Oaks, California, 91360-1847, United States

  • M Health Fairview University of Minnesota Medical Center - East Bank

    ACTIVE_NOT_RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • MedStar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • MercyOne Des Moines Medical Center

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • Methodist Hospital

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Montefiore Medical Center

    RECRUITING

    New York, New York, 10467-2401, United States

  • Montreal Heart Insitute

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Morton Plant

    RECRUITING

    Clearwater, Florida, 33756, United States

  • NYU Langone Hospital - Long Island

    ACTIVE_NOT_RECRUITING

    Mineola, New York, 11501, United States

  • NYU Langone Medical Center

    RECRUITING

    New York, New York, 10016, United States

  • New York-Presbyterian Hospital Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • North Florida Regional Medical Center

    RECRUITING

    Gainesville, Florida, 32605, United States

  • Northwell Health North Shore University Hospital

    RECRUITING

    Manhasset, New York, 11030, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • OhioHealth Riverside Methodist Hospital

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Oregon Health & Science University Hospital

    RECRUITING

    Portland, Oregon, 97239, United States

  • PIH Health Good Samaritan Hospital

    RECRUITING

    Los Angeles, California, 90017, United States

  • Piedmont Atlanta Hospital

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Providence Sacred Heart Medical Center & Children's Hospital

    RECRUITING

    Spokane, Washington, 99204, United States

  • Providence Saint Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

  • Providence St Patrick

    RECRUITING

    Missoula, Montana, 59802-4008, United States

  • Rigshospitalet

    WITHDRAWN

    Copenhagen, 2100, Denmark

  • Royal Columbian Hospital

    RECRUITING

    New Westminster, British Columbia, V3L 3W7, Canada

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Saint Francis Hospital

    RECRUITING

    Roslyn, New York, 11576, United States

  • Saint Mary's Hospital/Bon Secours

    WITHDRAWN

    Richmond, Virginia, 23226, United States

  • Saint Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • Saint Paul's Hospital

    RECRUITING

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Scripps Memorial Hospital

    RECRUITING

    La Jolla, California, 92037, United States

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507-1904, United States

  • Stanford Hospital and Clinics

    RECRUITING

    Stanford, California, 94305, United States

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Texas Health Presbyterian Hospital Dallas

    RECRUITING

    Dallas, Texas, 75231, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219-2906, United States

  • The Heart Hospital Baylor Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • The Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • The Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The Swedish Medical Center Cherry Hill

    WITHDRAWN

    Seattle, Washington, 98122, United States

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • The University of Vermont Medical Center

    RECRUITING

    Burlington, Vermont, 05401-1473, United States

  • UPMC Pinnacle Harrisburg Campus

    RECRUITING

    Harrisburg, Pennsylvania, 17101, United States

  • UPMC Presbyterian

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Alabama Birmingham (UAB) Hospital

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Maryland Medical Center

    COMPLETED

    Baltimore, Maryland, 21201, United States

  • University of Michigan Health System

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of South Florida Health

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Virginia Medical Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • University of Washington (UW) Medical Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Winchester Medical Center

    ACTIVE_NOT_RECRUITING

    Winchester, Virginia, 22601, United States

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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