New heart valve replacement could offer hope for patients with severe tricuspid leak

NCT ID NCT04482062

Ongoing Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device called EVOQUE that replaces the tricuspid valve in people with severe leakage (tricuspid regurgitation). The goal is to see if it is safe and can reduce leakage, improve symptoms, and enhance quality of life compared to standard medical therapy alone. About 864 adults with severe tricuspid regurgitation are participating.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart failure heart valve disorder tricuspid valve disorder tricuspid valve insufficiency

As listed by the trial registrant

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

CARDIOVASCULAR DISEASES HEART FAILURE HEART VALVE DISEASES TRICUSPID VALVE DISEASE TRICUSPID VALVE INSUFFICIENCY TRICUSPID VALVE REGURGITATION

Contacts and locations

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Locations

Ascension Via Christi St. Francis

Wichita, Kansas, 67214, United States
Baylor Heart Hopsital Plano

Plano, Texas, 75093, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
Carolinas Medical Center

Charlotte, North Carolina, 28203, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Columbia University Medical Center/NYPH

New York, New York, 10032, United States
Emory University

Atlanta, Georgia, 30308, United States
Florida Heart & Vascular Care - JFK

Atlantis, Florida, 33462, United States
HCA Houston Healthcare

Houston, Texas, 77004, United States
Henry Ford Health System

Detroit, Michigan, 48202, United States
Herz- und Diabeteszentrum NRW, Bad Oeynhausen

Bad Oeynhausen, 32545, Germany
Herzzentrum Dresden Universitätsklinik

Dresden, 01307, Germany
Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany
Herzzentrum Universitätsklinik Bonn

Bonn, 53105, Germany
Herzzentrum der Uniklinik Köln

Cologne, 50937, Germany
Intermountain Medical Center

Murray, Utah, 84107, United States
Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany
Kaiser Permanente San Francisco

San Francisco, California, 94118, United States
Kansas University Medical Center

Kansas City, Kansas, 66160, United States
Klinikum der Universität München - Großhadern

München, 81377, Germany
Lankenau Heart Institute

Wynnewood, Pennsylvania, 19096, United States
Lenox Hill Hospital

New York, New York, 10075, 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
Montefiore Medical Center

The Bronx, New York, 10461, United States
Morristown Medical Center

Morristown, New Jersey, 07960, United States
NCH Heart Institute

Naples, Florida, 34102, United States
NYU Langone Health

New York, New York, 10016, United States
North Shore University Hospital

Manhasset, New York, 11030, United States
Northwestern University

Chicago, Illinois, 60611, United States
Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States
Oregon Health & Science University

Portland, Oregon, 97293, United States
Piedmont Heart Institute

Atlanta, Georgia, 30309, United States
Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States
SJHMC Heart and Vascular Institute

Phoenix, Arizona, 85013, United States
Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States
Saint Thomas Health

Nashville, Tennessee, 37205, United States
Scripps Memorial Hospital La Jolla

La Jolla, California, 92037, United States
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
St. Francis Hospital

Roslyn, New York, 11576, United States
St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States
Stanford University

Stanford, California, 94305, United States
State University of New York at Buffalo

Buffalo, New York, 14203, United States
Swedish Medical Center

Seattle, Washington, 98122, United States
The Cardiac & Vascular Institute Research Foundation

Gainesville, Florida, 32605, United States
The Christ Hospital

Cincinnati, Ohio, 45219, United States
The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States
Tucson Medical Center

Tucson, Arizona, 85712, United States
UC Davis Medical Center

Sacramento, California, 95817, United States
University of California San Francisco

San Francisco, California, 94143, United States
University of Maryland

Baltimore, Maryland, 21201, United States
University of Michigan Hospital and Health Systems

Ann Arbor, Michigan, 48109, United States
University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
University of Virginia Health System

Charlottesville, Virginia, 22908, United States
University of Washington

Seattle, Washington, 98195, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States
Virginia Mason Franciscan Health

Seattle, Washington, 98101, United States
Weill Cornell Medicine-New York Presbyterian Hospital

New York, New York, 10021, United States