2019-06 TRISCEND Study

Last updated: February 14, 2025
Sponsor: Edwards Lifesciences
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vascular Diseases

Treatment

Transcatheter Tricuspid Valve Replacement

Clinical Study ID

NCT04221490
2019-06
  • Ages > 18
  • All Genders

Study Summary

Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Functional or degenerative TR moderate or greater

  • Symptomatic despite medical therapy or prior HF hospitalization from TR

  • The Local Site Heart Team determines that the patient is appropriate fortranscatheter tricuspid valve replacement

Exclusion

Key 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 in which the patient hasnot reached a primary endpoint

Study Design

Total Participants: 228
Treatment Group(s): 1
Primary Treatment: Transcatheter Tricuspid Valve Replacement
Phase:
Study Start date:
May 06, 2020
Estimated Completion Date:
January 31, 2029

Study Description

The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System.

Connect with a study center

  • St. Paul's Hospital Vancouver

    Vancouver, British Columbia V6Z1Y6
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)

    Québec, G1V 4G5
    Canada

    Site Not Available

  • CHU Bordeaux, Hôpital Cardiologique Haut Lévêque

    Pessac, 33600
    France

    Site Not Available

  • Clinique Pasteur

    Toulouse, 31076
    France

    Site Not Available

  • InselSpital University Hospital Bern

    Bern, 3010
    Switzerland

    Site Not Available

  • Universitätsspital Zürich

    Zürich, CH-8091
    Switzerland

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Stanford University

    Stanford, California 94305
    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

    Evanston, Illinois 60208
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Columbia University Irving Medical Center / NYPH

    New York, New York 10032
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    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

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