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New heart valve fix offers hope for those too sick for surgery

NCT ID NCT04153292

Disease control Sponsor: Edwards Lifesciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new device called SAPIEN M3 that can replace a leaky mitral heart valve using a thin tube inserted through a vein in the leg. It is for people with severe symptoms who cannot have standard surgery or other less invasive treatments. The goal is to see if the device is safe and helps reduce death and hospital stays for 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

About 900 people

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

Started

Nov 2020

Expected to finish

Feb 2031

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. 18 years of age or older 2. MR ≥ 3+ 3. NYHA functional class ≥ II 4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations. 5. Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment. 6. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve 2. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve 3. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation 4. Left ventricular ejection fraction \<25% 5. Severe right ventricular dysfunction 6. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months 7. History of heart transplant 8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 9. Active bacterial endocarditis within 180 days of the procedure 10. Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure 11. Myocardial infarction within 30 days of the procedure 12. Clinically significant untreated coronary artery disease requiring revascularization 13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure 14. Stroke or transient ischemic attack within 90 days of the procedure 15. Irreversible, severe pulmonary hypertension 16. Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use 17. Renal insufficiency or receiving renal replacement therapy 18. Liver disease 19. Planned surgery within the next 12 months 20. Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure 21. Active infection requiring current antibiotic therapy 22. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments 23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states 24. Refusal of blood products 25. Female who is pregnant or lactating 26. Estimated life expectancy \<12 months due to non-cardiac conditions 27. Participating in another investigational drug or device study that has not reached its primary endpoint 28. Subject considered to be part of a vulnerable population

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency

As listed by the trial registrant

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

Mitral regurgitation Mitral valve insufficiency

How to take part

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

  1. The places running it

    3 sites. 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

  • Alleghany General Hospital

    WITHDRAWN

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension St. Vincent's Hospital

    ACTIVE_NOT_RECRUITING

    Jacksonville, Florida, 32204, United States

  • Austin Heart

    ACTIVE_NOT_RECRUITING

    Austin, Texas, 78705, United States

  • Banner University Medical Center

    ACTIVE_NOT_RECRUITING

    Phoenix, Arizona, 85006, United States

  • Brigham & Women's

    WITHDRAWN

    Boston, Massachusetts, 02115, United States

  • California Pacific Medical Center

    ACTIVE_NOT_RECRUITING

    San Francisco, California, 94109, United States

  • Cardiac & Vascular Institute Foundation

    ACTIVE_NOT_RECRUITING

    Gainesville, Florida, 32605, United States

  • Cardiovascular Research Institute of Kansas (CRIOK)

    ACTIVE_NOT_RECRUITING

    Wichita, Kansas, 67226, United States

  • Carilion Roanoke Memorial Hospital

    ACTIVE_NOT_RECRUITING

    Roanoke, Virginia, 24014, United States

  • Carolinas Medical Center

    WITHDRAWN

    Charlotte, North Carolina, 28203, United States

  • Cedars-Sinai Medical Center

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90048, United States

  • CentraCare

    ACTIVE_NOT_RECRUITING

    Saint Cloud, Minnesota, 56303, United States

  • Cleveland Clinic Foundation

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44122, United States

  • Dartmouth-Hitchcock Medical Center

    ACTIVE_NOT_RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Delray Medical Center

    WITHDRAWN

    Delray Beach, Florida, 33484, United States

  • Emory University

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30308, United States

  • Good Samaritan Hospital

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90017, United States

  • HCA Houston Healthcare Medical (SCRI)

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77004, United States

  • Heart Center Hospital

    ACTIVE_NOT_RECRUITING

    Huntsville, Alabama, 35801, United States

  • Henry Ford

    ACTIVE_NOT_RECRUITING

    Detroit, Michigan, 48202, United States

  • Intermountain Medical Center

    ACTIVE_NOT_RECRUITING

    Murray, Utah, 84107, United States

  • Kaiser Sunset LA

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90071, United States

  • Laval University

    RECRUITING

    Québec, Quebec, G1V 0A6, Canada

  • Leiden University Medical Center

    ACTIVE_NOT_RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Massachusetts General Hospital

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    ACTIVE_NOT_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medstar Union Memorial Hospital

    ACTIVE_NOT_RECRUITING

    Baltimore, Maryland, 21218, United States

  • Minneapolis Heart

    WITHDRAWN

    Minneapolis, Minnesota, 55407, United States

  • Morristown Medical Center

    WITHDRAWN

    Morristown, New Jersey, 07962, United States

  • Mount Carmel East Hospital

    ACTIVE_NOT_RECRUITING

    Columbus, Ohio, 43123, United States

  • Naples Community Hospital

    ACTIVE_NOT_RECRUITING

    Naples, Florida, 34102, United States

  • Northshore University Health System

    ACTIVE_NOT_RECRUITING

    Glenview, Illinois, 60026, United States

  • Novant Health and Vascular Institute

    ACTIVE_NOT_RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Oklahoma Heart Hospital

    ACTIVE_NOT_RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Oklahoma Heart Institute

    ACTIVE_NOT_RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Our Lady of the Lake Regional Medical Center

    ACTIVE_NOT_RECRUITING

    Baton Rouge, Louisiana, 70808, United States

  • Piedmont Healthcare

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30309, United States

  • Rabin Medical Center

    ACTIVE_NOT_RECRUITING

    Petah Tikva, 4941492, Israel

  • Robert Wood Johnson University Hospital

    ACTIVE_NOT_RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Rotterdam Erasmus MC

    ACTIVE_NOT_RECRUITING

    Rotterdam, 3015 CE, Netherlands

  • Royal Prince Alfred Hospital

    ACTIVE_NOT_RECRUITING

    Camperdown, NSW2050, Australia

  • Rush University Medical Center

    WITHDRAWN

    Chicago, Illinois, 60612, United States

  • Saint Bartholomew's Medical Center

    ACTIVE_NOT_RECRUITING

    London, EC1A 7BE, United Kingdom

  • Saint Joseph Hospital

    WITHDRAWN

    Orange, California, 92868, United States

  • Saint Josephs Hospital Medical Center Dignity Health

    ACTIVE_NOT_RECRUITING

    Phoenix, Arizona, 85013, United States

  • Saint Luke's Kansas City

    ACTIVE_NOT_RECRUITING

    Kansas City, Missouri, 64111, United States

  • Saint Thomas Health

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 37205, United States

  • Saint Thomas Hospital

    ACTIVE_NOT_RECRUITING

    London, SE1 7EH, United Kingdom

  • Sarasota Memorial Hospital

    ACTIVE_NOT_RECRUITING

    Sarasota, Florida, 34239, United States

  • Scripps Health

    ACTIVE_NOT_RECRUITING

    La Jolla, California, 92037, United States

  • Sentara Norfolk

    ACTIVE_NOT_RECRUITING

    Norfolk, Virginia, 23507, United States

  • Shaare Zedek Medical Center

    WITHDRAWN

    Jerusalem, 9103102, Israel

  • Sheba Medical Center

    WITHDRAWN

    Ramat Gan, 5211401, Israel

  • St. Michael's

    RECRUITING

    Toronto, M5B 1W8, Canada

  • St. Patrick Hospital

    WITHDRAWN

    Missoula, Montana, 59802, United States

  • St. Pauls

    RECRUITING

    Vancouver, V6E 1M7, Canada

  • St. Vincent Heart Center of Indiana

    WITHDRAWN

    Indianapolis, Indiana, 46290, United States

  • TMC Healthcare

    WITHDRAWN

    Tucson, Arizona, 85712, United States

  • The Christ Hospital

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Prince Charles Hospital

    ACTIVE_NOT_RECRUITING

    Chermside, Queensland, 4032, Australia

  • UC Health Northern Colorado (Medical Center of the Rockies)

    ACTIVE_NOT_RECRUITING

    Loveland, Colorado, 80538, United States

  • UPMC Heart and Vascular Institute

    ACTIVE_NOT_RECRUITING

    Mechanicsburg, Pennsylvania, 17050, United States

  • UT Memorial Hermann

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • University of Buffalo

    ACTIVE_NOT_RECRUITING

    Buffalo, New York, 14203, United States

  • University of Kansas

    ACTIVE_NOT_RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Washington Seattle

    ACTIVE_NOT_RECRUITING

    Seattle, Washington, 98195, United States

  • University of Wisconsin

    WITHDRAWN

    Madison, Wisconsin, 53792-3248, United States

  • Weill Cornell Medicine

    ACTIVE_NOT_RECRUITING

    New York, New York, 10007, United States

More trials for these conditions

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