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New heart valve fix device takes on market leader in major trial

NCT ID NCT03706833

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study compares two devices—the Edwards PASCAL and the Abbott MitraClip—that repair leaky mitral heart valves without open-heart surgery. About 1,200 people with severe mitral regurgitation who are too high-risk for surgery are being randomly assigned to one device. The goal is to see if the PASCAL system is as safe and effective as the MitraClip in reducing valve leakage, improving symptoms, and preventing hospitalizations or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Edwards PASCAL System (a device to repair the mitral valve without open-heart surgery)
What this could lead to
If successful, this could provide a safer, less invasive option for people with leaky heart valves who are too frail for surgery, potentially reducing hospitalizations and improving quality of life.
What could go wrong
This is a large, advanced trial, but it compares two similar devices, so the benefit over existing treatment may be small. Risks include bleeding, infection, or the device not working as well as hoped.

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 1,247 people

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

Started

Nov 2018

Expected to finish

Jun 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: * Eighteen (18) years of age or older * Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements. * Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only). * Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only) * Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip * Mitral regurgitation (3+ to 4+) by echo * Suitable valve and regurgitant jet morphology * Elevated corrected BNP \> 400 pg/ml or corrected NT-pro BNP of \> 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only) * LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only) Exclusion Criteria: * Patient in whom a TEE is contraindicated or screening TEE is unsuccessful * Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation * Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure) * Clinically significant, untreated coronary artery disease * Recent stroke * Other severe valve disorders requiring intervention * Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months * Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair) * Severe tricuspid regurgitation or tricuspid valve disease requiring surgery * Active rheumatic heart disease or rheumatic etiology for MR * Severe aortic stenosis or regurgitation * Known history of untreated, severe carotid stenosis * Recent deep vein thrombosis (DVT) or pulmonary embolism (PE) * Severe COPD * Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception * Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator * Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment * Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship

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Conditions

The condition(s) this trial relates to.

mitral valve disorder mitral valve insufficiency

As listed by the trial registrant

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

Degenerative mitral valve disease Functional mitral regurgitation Mitral insufficiency Mitral regurgitation

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Albany Medical College

    Albany, New York, 12208, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Banner University Medical Center

    Phoenix, Arizona, 85006, United States

  • Baptist Memorial Hospital Memphis

    Memphis, Tennessee, 38138, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Woman's Hospital

    Boston, Massachusetts, 02115, United States

  • CVA Heart Institute Kingsport

    Kingsport, Tennessee, 37660, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) ULaval

    Québec, G1V 4G5, Canada

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Emory University Hospital and Emory University Hospital Midtown

    Atlanta, Georgia, 30322, United States

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2, Canada

  • Helios Klinikum Siegburg

    Siegburg, 53721, Germany

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Herrzentrum Dresden GmbH Universitätklinik an der Technischen Universität Dresden

    Dresden, 01307, Germany

  • Herzzentrum Leipzig Universitätsklinik für Kardiologie

    Leipzig, 04289, Germany

  • Herzzentrum Universitätsklinikum Koln

    Cologne, 50937, Germany

  • Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Intermountain Medical Center

    Salt Lake City, Utah, 84107, United States

  • Kaiser Permanente San Francisco

    San Francisco, California, 94118, United States

  • Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum

    Bad Oeynhausen, 32545, Germany

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Lenox Hill Hospital and North Shore University

    New York, New York, 10075, United States

  • Los Robles Hospital and Medical Center

    Thousand Oaks, California, 91360, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical Center of the Rockies

    Loveland, Colorado, 80538, United States

  • Medizinische Klinik I LMU München Campus Grosshadern

    München, 81377, Germany

  • Medstar Washington Hospital Center

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

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8, Canada

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Mount Sinai

    Miami Beach, Florida, 33140, United States

  • NCH Rooney Heart Institute

    Naples, Florida, 34102, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oklahoma Cardiovascular

    Oklahoma City, Oklahoma, 73120, United States

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Piedmont Healthcare

    Atlanta, Georgia, 30309, United States

  • Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg

    Wormleysburg, Pennsylvania, 17043, United States

  • Rochester General Hospital

    Rochester, New York, 14621, United States

  • Rutgers-RWJMS

    New Brunswick, New Jersey, 08901, United States

  • Saint Thomas Heart at Saint Thomas West

    Nashville, Tennessee, 37205, United States

  • Scripps Memorial Hospital La Jolla

    La Jolla, California, 92071, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • St. Pauls Hospital

    Vancouver, British Columbia, V6E 1M7, Canada

  • St. Vincent Heart Center

    Carmel, Indiana, 46290, United States

  • St.Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Stanford University

    Stanford, California, 94305, United States

  • State University of New York at Buffalo

    Buffalo, New York, 14203, United States

  • Sutter Medical Center-Sacramento

    Sacramento, California, 95618, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • TMC Healthcare

    Tucson, Arizona, 85712, United States

  • The Cardiac and Vascular Institute Research Foundation

    Gainesville, Florida, 32605, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219-2906, United States

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • UC Irvine

    Orange, California, 92868, United States

  • ULM University Zentrum für Innere Medizin Klinik für Innere Medizin II

    Ulm, 89081, Germany

  • University Hospital Bern

    Bern, 3010, Switzerland

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Universitäres Herzzentrum Hamburg GmbH (UHZ) Klinik und Poliklinik für Allgemeneine und Interventionelle Kardiologie

    Hamburg, 20246, Germany

  • Universitätsklinikum Essen (AöR) Klinik für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum

    Essen, 45174, Germany

  • Universitätsklinikum Gießen Medizinische Klinik I, Innere Medizin/ Kardiologie

    Giessen, 35392, Germany

  • Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie, Pneumologie

    Heidelberg, 69120, Germany

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Washington University/Barnes Jewish Hospital

    St Louis, Missouri, 63110, United States

  • WellSpan York Hospital

    York, Pennsylvania, 17405, United States

  • Zentrum für Kardiologie - Kardiologie I Universitätsmedizin der Johannes Gutenberg Universität Mainz

    Mainz, 55131, Germany

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