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TRISCEND II Pivotal Trial

Sponsor
Edwards Lifesciences (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04482062
Collaborator
(none)
820
Enrollment
51
Locations
3
Arms
85.7
Anticipated Duration (Months)
16.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Edwards EVOQUE System
  • Drug: Optimal Medical Therapy
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
820 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
Actual Study Start Date :
Apr 9, 2021
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Edwards EVOQUE System & OMT

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation

Device: Edwards EVOQUE System
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
Other Names:
  • Transcatheter tricuspid valve replacement

    		•
    Active Comparator: Optimal Medical Therapy (OMT)

    Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation

    Drug: Optimal Medical Therapy
    Optimal Medical Therapy
    Experimental: Single-Arm Registry

    Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization

    Device: Edwards EVOQUE System
    Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
    Other Names:
  • Transcatheter tricuspid valve replacement

    		•

    Outcome Measures

    Primary Outcome Measures

    1. TR Grade reduction and composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement [6 months]

      Comparison of number of participants with reduction in TR and composite endpoint event improvement between experimental and active comparator arms

    2. Rate of Major Adverse Events (MAE) [30 days]

      Rate of Major Adverse Events (MAE) in experimental arm

    3. Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6-minute walk distance improvement [1 year]

      Comparison of number of participants with composite endpoint events between experimental and active comparator arms

    Secondary Outcome Measures

    1. Composite endpoint including reduction in TR grade, change in QOL from baseline, death and heart failure hospitalization, all-cause hospitalization, all-cause mortality, and change in right ventricular end diastolic volume index [1 year]

      Hierarchical comparison of number of participants with composite endpoint events between experimental and active comparator arms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 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 has not reached a primary endpoint

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scripps Memorial Hospital La Jolla La Jolla California United States 92037
    2 Cedars-Sinai Medical Center Los Angeles California United States 90048
    3 Kaiser Permanente San Francisco San Francisco California United States 94118
    4 Stanford University Stanford California United States 94305
    5 Medical Center of the Rockies Loveland Colorado United States 80538
    6 The Cardiac & Vascular Institute Research Foundation Gainesville Florida United States 32605
    7 Emory University Atlanta Georgia United States 30308
    8 Piedmont Heart Institute Atlanta Georgia United States 30309
    9 Northwestern University Chicago Illinois United States 60611
    10 St. Vincent Heart Center of Indiana Indianapolis Indiana United States 46290
    11 Cardiovascular Research Institute of Kansas Wichita Kansas United States 67226
    12 University of Maryland Baltimore Maryland United States 21201
    13 Johns Hopkins Hospital Baltimore Maryland United States 21287
    14 Massachusetts General Hospital Boston Massachusetts United States 02114
    15 Brigham and Women's Hospital Boston Massachusetts United States 02115
    16 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    17 University of Michigan Hospital and Health Systems Ann Arbor Michigan United States 48109
    18 Henry Ford Health System Detroit Michigan United States 48202
    19 Mayo Clinic Rochester Minnesota United States 55905
    20 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    21 Morristown Medical Center Morristown New Jersey United States 07960
    22 Rutgers Robert Wood Johnson Medical School New Brunswick New Jersey United States 08903
    23 Montefiore Medical Center Bronx New York United States 10461
    24 State University of New York at Buffalo Buffalo New York United States 14203
    25 NYU Langone Health New York New York United States 10016
    26 Weill Cornell Medicine-New York Presbyterian Hospital New York New York United States 10021
    27 Columbia University Medical Center/NYPH New York New York United States 10032
    28 Lenox Hill Hospital New York New York United States 10075
    29 St. Francis Hospital Roslyn New York United States 11576
    30 Carolinas Medical Center Charlotte North Carolina United States 28203
    31 The Christ Hospital Cincinnati Ohio United States 45219
    32 Cleveland Clinic Cleveland Ohio United States 44195
    33 Oklahoma Heart Institute Tulsa Oklahoma United States 74104
    34 Oregon Health & Science University Portland Oregon United States 97293
    35 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    36 Lankenau Heart Institute Wynnewood Pennsylvania United States 19096
    37 Saint Thomas Health Nashville Tennessee United States 37205
    38 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    39 The University of Texas Health Science Center at Houston Houston Texas United States 77030
    40 Baylor Heart Hopsital Plano Plano Texas United States 75093
    41 Intermountain Medical Center Murray Utah United States 84107
    42 University of Virginia Health System Charlottesville Virginia United States 22908
    43 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
    44 University of Washington Seattle Washington United States 98195
    45 Herz- und Diabeteszentrum NRW, Bad Oeynhausen Bad Oeynhausen Germany 32545
    46 Herzzentrum Universitätsklinik Bonn Bonn Germany 53105
    47 Herzzentrum Dresden Universitätsklinik Dresden Germany 01307
    48 Herzzentrum der Uniklinik Köln Köln Germany 50937
    49 Herzzentrum Leipzig GmbH Leipzig Germany 04289
    50 Johannes Gutenberg-Universität Mainz Mainz Germany 55131
    51 Klinikum der Universität München - Großhadern München Germany 81377

    Sponsors and Collaborators

    • Edwards Lifesciences

    Investigators

    • Principal Investigator: James Gammie, MD, Johns Hopkins Health System
    • Principal Investigator: Rebecca Hahn, MD, Columbia University
    • Principal Investigator: Susheel Kodali, MD, Columbia University
    • Principal Investigator: Philipp Lurz, MD, Herzzentrum Leipzig GmbH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edwards Lifesciences
    ClinicalTrials.gov Identifier:
    NCT04482062
    Other Study ID Numbers:
    • 2020-05
    First Posted:
    Jul 22, 2020
    Last Update Posted:
    Jul 13, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Heart Valve Diseases
    Tricuspid Valve Insufficiency

    Study Results

    No Results Posted as of Jul 13, 2022