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New heart device could rival surgery for leaky valve patients

NCT ID NCT04198870

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests if a device called MitraClip, which fixes a leaky mitral valve without open-heart surgery, works as well as traditional surgery. About 500 people with severe mitral regurgitation who are at moderate risk for surgery will take part. The goal is to see if the device can prevent death, stroke, or heart-related hospital stays as effectively as surgery.

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 500 people

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

Started

Jul 2020

Expected to finish

Dec 2035

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. Subject has severe (Grade III or greater per the ASE criteria, which includes severity grades of 3+ and 4+) primary MR (mixed etiology is acceptable provided the principal mechanism of action is a degenerative mitral valve) as assessed by the ECL. 2. The cardiac surgeon of the Site Heart Team (consisting of at least one interventionalist, and one cardiac surgeon) has confirmed that the subject is a candidate for mitral valve surgery and the EC have confirmed that the subject's mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild 3. Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery systolic pressure \> 50 mmHg, or LVESD \> 40 mm 4. Subject is at moderate surgical risk defined as being at least 75 years of age at the time of EC review. If younger than 75 years, then the subject should have: 1. Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR 2. Presence of other comorbidities which may introduce a potential surgery-specific impediment 5. Subject provides written informed consent 6. Subject is ≥ 18 years of age Exclusion Criteria: 1. Subject is currently participating in another clinical investigation 2. 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. 3. Subject has ischemic or non-ischemic secondary MR 4. Concomitant severe tricuspid valve regurgitation 5. Ejection fraction \<30% 6. Severe mitral annular calcification 7. Acute myocardial infarction in the past 12 weeks 8. Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease 9. Subjects who have concurrent coronary artery disease that needs to be treated may be included provided the subjects are eligible for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery. Subjects randomized to the device group, must undergo PCI before the MitraClip™ device procedure. Subjects randomized to the surgical (control) arm may undergo coronary artery revascularization during mitral valve repair surgery 10. Surgical procedure performed in the past 30 days 11. Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT 12. Transesophageal echocardiography (TEE) is contraindicated. 13. Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or IABP 14. Need for emergency surgery for any reason 15. Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or VAD 16. Systolic anterior motion of the mitral valve 17. Hypertrophic cardiomyopathy 18. Renal insufficiency requiring dialysis 19. Active infections requiring current antibiotic therapy

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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 valve regurgitation

Contacts and locations

Locations

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Allegheny General Hospital - ASRI

    Pittsburgh, Pennsylvania, 15212, United States

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016, United States

  • Ascension Saint Thomas

    Nashville, Tennessee, 37205, United States

  • Ascension St. Vincent

    Indianapolis, Indiana, 46240, United States

  • Ascension Texas Cardiovascular Research

    Austin, Texas, 78705, United States

  • Banner-University Medical Center Phoenix

    Phoenix, Arizona, 85006, United States

  • Baptist Medical Center

    Jacksonville, Florida, 32207, United States

  • Beaumont Hospital, Royal Oak

    Royal Oak, Michigan, 48073, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cardiology Associates of Mobile, Inc.

    Mobile, Alabama, 36608, United States

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226, United States

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Center Inselspital Bern

    Bern, Canton of Bern, 3010, Switzerland

  • Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • Cooper University Hospital

    Camden, New Jersey, 08103, United States

  • Deutsches Herzzentrum München des Freistaates Bayern

    München, 80636, Germany

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • HCA Houston Healthcare Medical Center

    Houston, Texas, 77004, United States

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • Herz-und Diabetes Zentrum NRW

    Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

    Montreal, Quebec, H1T 1C8, Canada

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112, United States

  • Intermountain Medical Center

    Murray, Utah, 84157, United States

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

  • Kansas University Medical Center

    Kansas City, Kansas, 66160, United States

  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

    Frankfurt am Main, Hesse, 60590, Germany

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, 19096, United States

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mercy General Hospital

    Sacramento, California, 95819, United States

  • Mission Health & Hospitals

    Asheville, North Carolina, 28801, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07962, United States

  • Mt. Carmel East

    Columbus, Ohio, 43213, United States

  • NCH Healthcare System

    Naples, Florida, 34102, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • New York-Presbyterian/Columbia University Medical Center

    New York, New York, 10032, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Pinnacle Health Cardiovascular Institute, Inc.

    Harrisburg, Pennsylvania, 17105, United States

  • Prairie Education & Research Cooperative

    Springfield, Illinois, 62701, United States

  • Rochester Regional Health

    Rochester, New York, 14617, United States

  • Saint Joseph Hospital

    Denver, Colorado, 80218, United States

  • Scripps Health

    La Jolla, California, 92037, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • South Shore University Hospital

    Bay Shore, New York, 11706, United States

  • St. Francis Hospital

    Roslyn, New York, 11576, United States

  • St. Josephs Hospital and Medical Center

    Phoenix, Arizona, 85013, United States

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M5N 3M5, Canada

  • Sutter Medical Center, Sacramento

    Sacramento, California, 95816, United States

  • Swedish Medical Center

    Seattle, Washington, 98107, United States

  • The Heart Institute at Virginia Mason

    Seattle, Washington, 98111, United States

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • Tucson Medical Center

    Tucson, Arizona, 85712, United States

  • UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • UTHealth Memorial Hermann

    Houston, Texas, 77008, United States

  • University Hospital - Univ. of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35249, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, 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 Michigan Medical Center

    Ann Arbor, Michigan, 48104, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

  • Universitätsklinikum Rostock (AöR)

    Rostock, 18057, Germany

  • Universitätsklinikum Ulm

    Ulm, Bad-wur, 89081, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Rhinela, 55131, Germany

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee, 37232, United States

  • Via Christi Regional Medical Center - St. Francis Campus

    Wichita, Kansas, 67214, United States

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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