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New heart valve repair device could spare patients from major surgery

NCT ID NCT04097145

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 4 times

Summary

This study tests a device called the Edwards PASCAL System, which is threaded through a blood vessel to repair a leaky tricuspid valve in the heart. It is for people with severe symptoms who are not good candidates for open-heart surgery. About 1,270 participants will be randomly assigned to get the device plus medication, or medication alone, to see if the device improves survival, reduces hospital stays, and boosts quality of life.

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 Transcatheter Valve Repair System (a device inserted through a blood vessel to repair the tricuspid valve)
What this could lead to
If successful, this could offer a less invasive treatment option for people with severe tricuspid valve leakage who are too high-risk for surgery, potentially reducing symptoms and hospitalizations.
What could go wrong
This is a pivotal trial but still experimental. The device may not work for everyone, and risks include complications from the procedure itself. It is not a cure, as patients may still need ongoing medication.

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 1,270 people

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

Started

Dec 2019

Expected to finish

Dec 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 * Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR. * Severe or greater tricuspid regurgitation * New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months * Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team * Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements Exclusion Criteria: * Tricuspid valve anatomy not evaluable by TTE or TEE * Tricuspid valve anatomy precludes proper device deployment and function * Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D heart failure) * Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following: 1. Would prevent proper TR reduction due to interaction of the lead with the leaflets 2. Were implanted in the RV within the last 90 days prior to the point of enrollment * Primary non-degenerative tricuspid disease * Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL * Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction * Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment * Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days * Recent Stroke * Active gastrointestinal (GI) bleeding * Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease, including but not limited to atrial septal defect, RV dysplasia, and arrhythmogenic RV * Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days * Any of the following cardiovascular procedures: 1. Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment 2. Carotid surgery within 30 days prior to the point of enrollment 3. Direct current cardioversion within the last 30 days prior to the point of enrollment 4. Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment 5. Cardiac surgery within 90 days prior to the point of enrollment * Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation * Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid stenosis * Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days * Patient is oxygen-dependent or requires continuous home oxygen * Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days) * 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 * Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship * Any patient considered to be vulnerable

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Conditions

The condition(s) this trial relates to.

tricuspid valve disorder tricuspid valve insufficiency

As listed by the trial registrant

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

Tricuspid regurgitation Tricuspid valve disease Tricuspid valve insufficiency

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    45 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ascension St. Vincent Heart Center Cardiovascular Research Institute

    RECRUITING

    Indianapolis, Indiana, 46290, United States

  • Banner University Medical Center Phoenix

    ACTIVE_NOT_RECRUITING

    Phoenix, Arizona, 85006, United States

  • Baylor College of Medicine St. Luke's Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Baylor Scott & White - The Heart Hospital - Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • Carilion Medical Center

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Cedars Sinai Medical Center

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90048, United States

  • Columbia University Irving Medical Center/NYPH

    RECRUITING

    New York, New York, 10032, United States

  • Cooper Health Systems

    RECRUITING

    Camden, New Jersey, 09103, United States

  • Dartmouth-Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Emory University Hospital Midtown / Emory University - St. Joseph's Hospital

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Erlanger Health System

    ACTIVE_NOT_RECRUITING

    Chattanooga, Tennessee, 37403, United States

  • Fairview Health Services

    ACTIVE_NOT_RECRUITING

    Maplewood, Minnesota, 55109, United States

  • HCA Houston Healthcare Medical Center

    RECRUITING

    Houston, Texas, 77004, United States

  • Hamilton Health Services

    ACTIVE_NOT_RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

    ACTIVE_NOT_RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • Integris Baptist Medical Center

    ACTIVE_NOT_RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • Intermountain Medical Center

    ACTIVE_NOT_RECRUITING

    Murray, Utah, 84107, United States

  • Johns Hopkins

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kaiser Permanente San Francisco

    ACTIVE_NOT_RECRUITING

    San Francisco, California, 94118, United States

  • Lankenau Heart Institute

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset

    RECRUITING

    New York, New York, 10075, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical Center of the Rockies

    ACTIVE_NOT_RECRUITING

    Loveland, Colorado, 80538, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    ACTIVE_NOT_RECRUITING

    Charleston, South Carolina, 29245, United States

  • Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital

    RECRUITING

    The Bronx, New York, 10467, United States

  • Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07962, United States

  • Mount Sinai Medical Center

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • NCH Healthcare System

    RECRUITING

    Naples, Florida, 34102, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Ochsner Medical Center

    ACTIVE_NOT_RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Oklahoma Cardiovascular Research Group

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Oklahoma Heart Institute at Hillcrest Medical Center

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Penn State Hershey

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

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

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Piedmont Healthcare, Inc.

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30309, United States

  • Pinnacle Health Cardiovascular Institute/UPMC Pinnacle

    RECRUITING

    Wormleysburg, Pennsylvania, 17043, United States

  • Providence St. Patrick Hospital

    ACTIVE_NOT_RECRUITING

    Missoula, Montana, 59802, United States

  • Rochester General Hospital

    ACTIVE_NOT_RECRUITING

    Rochester, New York, 14621, United States

  • Rutgers Robert Wood Johnson Medical School

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • SCPMG - Kaiser San Diego

    ACTIVE_NOT_RECRUITING

    La Jolla, California, 92037, United States

  • Saint Luke's Hospital of Kansas City

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Sanford Medical Center Fargo

    ACTIVE_NOT_RECRUITING

    Fargo, North Dakota, 58104, United States

  • Sarasota Memorial Health Care System

    RECRUITING

    Sarasota, Florida, 34239, United States

  • St. Francis Hospital

    RECRUITING

    Roslyn, New York, 11576, United States

  • St. George Regional Hospital

    RECRUITING

    St. George, Utah, 84790, United States

  • St. Joseph Hospital

    RECRUITING

    Denver, Colorado, 80218, United States

  • St. Mary's of Ascension Research

    ACTIVE_NOT_RECRUITING

    Saginaw, Michigan, 48601, United States

  • St. Michael's Hospital

    ACTIVE_NOT_RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • St. Paul's Hospital

    ACTIVE_NOT_RECRUITING

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Stanford University

    ACTIVE_NOT_RECRUITING

    Stanford, California, 94305, United States

  • State University of New York at Buffalo

    RECRUITING

    Buffalo, New York, 14203, United States

  • Sunnybrook Health Sciences Centre

    ACTIVE_NOT_RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Swedish Medical Center

    ACTIVE_NOT_RECRUITING

    Seattle, Washington, 98122, United States

  • Tallahassee Research Institute

    ACTIVE_NOT_RECRUITING

    Tallahassee, Florida, 32308, United States

  • The Cardiac and Vascular Institute Research Foundation

    RECRUITING

    Gainesville, Florida, 32605, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • TriHealth-Bethesda North Hospital

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Tucson Medical Center Healthcare

    ACTIVE_NOT_RECRUITING

    Tucson, Arizona, 85712, United States

  • UCLA Medical Center

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90095, United States

  • UTHealth/Memorial Hermann Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • University of California, Irvine

    RECRUITING

    Irvine, California, 92868, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Iowa Hospitals & Clinics

    ACTIVE_NOT_RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27517, United States

  • University of Ottawa Heart Institute

    ACTIVE_NOT_RECRUITING

    Ottawa, Ontario, K1Y 4Q7, Canada

  • University of Virginia Health System

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Vanderbilt University Medical Center

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 37212, United States

  • Virginia Commonwealth University

    ACTIVE_NOT_RECRUITING

    Richmond, Virginia, 23298, United States

  • Virginia Mason Medical Center

    RECRUITING

    Seattle, Washington, 98101, United States

  • Washington University School of Medicine

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10065, United States

  • William Beaumont Hospital - Royal Oak

    ACTIVE_NOT_RECRUITING

    Royal Oak, Michigan, 48073, United States

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