TRISCEND II Pivotal Trial

Last updated: April 1, 2025
Sponsor: Edwards Lifesciences
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vascular Diseases

Chest Pain

Heart Valve Disease

Treatment

Optimal Medical Therapy

Edwards EVOQUE System

Clinical Study ID

NCT04482062
2020-05
  • Ages > 18
  • All Genders

Study Summary

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Symptomatic tricuspid regurgitation (TR) despite medical therapy

  • TR graded as severe or greater

  • Appropriate for transcatheter tricuspid valve replacement per the local heart team

Exclusion

Exclusion Criteria:

  • Tricuspid valve anatomic contraindications

  • Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months

  • Hemodynamic instability

  • Refractory heart failure requiring advanced intervention

  • Currently participating in another investigational study

Study Design

Total Participants: 1070
Treatment Group(s): 2
Primary Treatment: Optimal Medical Therapy
Phase:
Study Start date:
April 09, 2021
Estimated Completion Date:
December 31, 2029

Study Description

The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

Connect with a study center

  • Herz- und Diabeteszentrum NRW, Bad Oeynhausen

    Bad Oeynhausen, 32545
    Germany

    Site Not Available

  • Herzzentrum Universitätsklinik Bonn

    Bonn, 53105
    Germany

    Site Not Available

  • Herzzentrum Dresden Universitätsklinik

    Dresden, 01307
    Germany

    Site Not Available

  • Herzzentrum der Uniklinik Köln

    Köln, 50937
    Germany

    Site Not Available

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289
    Germany

    Site Not Available

  • Johannes Gutenberg-Universität Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Klinikum der Universität München - Großhadern

    München, 81377
    Germany

    Site Not Available

  • SJHMC Heart and Vascular Institute

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Tucson Medical Center

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Scripps Memorial Hospital La Jolla

    La Jolla, California 92037
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Kaiser Permanente San Francisco

    San Francisco, California 94118
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • Medical Center of the Rockies

    Loveland, Colorado 80538
    United States

    Site Not Available

  • Florida Heart & Vascular Care - JFK

    Atlantis, Florida 33462
    United States

    Site Not Available

  • The Cardiac & Vascular Institute Research Foundation

    Gainesville, Florida 32605
    United States

    Site Not Available

  • NCH Heart Institute

    Naples, Florida 34102
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Piedmont Heart Institute

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Ascension Via Christi St. Francis

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas 67226
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan Hospital and Health Systems

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Washington University Barnes-Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • State University of New York at Buffalo

    Buffalo, New York 14203
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Columbia University Medical Center/NYPH

    New York, New York 10032
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Weill Cornell Medicine-New York Presbyterian Hospital

    New York, New York 10021
    United States

    Site Not Available

  • Rochester General Hospital

    Rochester, New York 14621
    United States

    Site Not Available

  • St. Francis Hospital

    Roslyn, New York 11576
    United States

    Site Not Available

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Oklahoma Heart Institute

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97293
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Lankenau Heart Institute

    Wynnewood, Pennsylvania 19096
    United States

    Site Not Available

  • Saint Thomas Health

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • HCA Houston Healthcare

    Houston, Texas 77004
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor Heart Hopsital Plano

    Plano, Texas 75093
    United States

    Site Not Available

  • Intermountain Medical Center

    Murray, Utah 84107
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • Virginia Mason Franciscan Health

    Seattle, Washington 98101
    United States

    Site Not Available

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