TRISCEND II Pivotal Trial

January 12, 2024 updated by: Edwards Lifesciences

Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1070

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Active, not recruiting
        • Herz- und Diabeteszentrum NRW, Bad Oeynhausen
      • Bonn, Germany, 53105
        • Active, not recruiting
        • Herzzentrum Universitätsklinik Bonn
      • Dresden, Germany, 01307
        • Active, not recruiting
        • Herzzentrum Dresden Universitätsklinik
      • Köln, Germany, 50937
        • Active, not recruiting
        • Herzzentrum der Uniklinik Köln
      • Leipzig, Germany, 04289
        • Active, not recruiting
        • Herzzentrum Leipzig GmbH
      • Mainz, Germany, 55131
        • Active, not recruiting
        • Johannes Gutenberg-Universität Mainz
      • München, Germany, 81377
        • Active, not recruiting
        • Klinikum der Universität München - Großhadern
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • SJHMC Heart and Vascular Institute
        • Principal Investigator:
          • Hursh Naik, MD
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Tucson Medical Center
        • Principal Investigator:
          • Thomas Waggoner, DO
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Scripps Memorial Hospital La Jolla
        • Principal Investigator:
          • Curtiss Stinis, MD
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Raj Makkar, MD
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Medical Center
        • Principal Investigator:
          • Gagan Singh, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco
        • Principal Investigator:
          • Sammy Elmariah, MD
      • San Francisco, California, United States, 94118
        • Recruiting
        • Kaiser Permanente San Francisco
        • Principal Investigator:
          • Andrew Rassi, MD
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Rahul P Sharma, MBBS
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Active, not recruiting
        • Medical Center of the Rockies
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • Florida Heart & Vascular Care - JFK
        • Principal Investigator:
          • Marcos Nores, MD
      • Gainesville, Florida, United States, 32605
        • Recruiting
        • The Cardiac & Vascular Institute Research Foundation
        • Principal Investigator:
          • Charles Klodell, MD
      • Naples, Florida, United States, 34102
        • Recruiting
        • NCH Heart Institute
        • Principal Investigator:
          • Robert Cubeddu, MD
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Principal Investigator:
          • Pradeep Yadav, MD
        • Principal Investigator:
          • Vinod Thourani, MD
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Vasilis Babaliaros, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Charles Davidson, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Recruiting
        • St. Vincent Heart Center of Indiana
        • Principal Investigator:
          • James Hermiller, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • Kansas University Medical Center
        • Principal Investigator:
          • Peter Tadros, MD
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Cardiovascular Research Institute of Kansas
        • Principal Investigator:
          • Bassem Chehab
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Principal Investigator:
          • Bradley Taylor, MD
      • Baltimore, Maryland, United States, 21287
        • Withdrawn
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Pinak B Shah, MD
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Ignacio Inglessis, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Roger Laham, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Hospital and Health Systems
        • Principal Investigator:
          • Gorav Ailawadi, MD
        • Principal Investigator:
          • Stanley Chetcuti, MD
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Principal Investigator:
          • Brian P. O'Neill, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Mackram Eleid, MD
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke'S Hospital of Kansas City
        • Principal Investigator:
          • Adnan Chhatriwalla, MD
      • Saint Louis, Missouri, United States, 63110
        • Withdrawn
        • Washington University Barnes-Jewish Hospital
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
        • Principal Investigator:
          • Robert Kipperman, MD
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Robert Wood Johnson Medical School
        • Principal Investigator:
          • Mark Russo, MD
    • New York
      • Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • M. Azeem Latib, MD
      • Buffalo, New York, United States, 14203
        • Recruiting
        • State University of New York at Buffalo
        • Principal Investigator:
          • Vijay Iyer, MD
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital
        • Principal Investigator:
          • Bruce Rutkin, MD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Principal Investigator:
          • Cezar S. Staniloae, MD
        • Principal Investigator:
          • Mathew Williams, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/NYPH
        • Principal Investigator:
          • Susheel Kodali, MD
      • New York, New York, United States, 10075
        • Active, not recruiting
        • Lenox Hill Hospital
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medicine-New York Presbyterian Hospital
        • Principal Investigator:
          • Mark Reisman, MD
      • Rochester, New York, United States, 14621
        • Withdrawn
        • Rochester General Hospital
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital
        • Principal Investigator:
          • George A Petrossian, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina - Chapel Hill
        • Principal Investigator:
          • John Paul Vavalle, MD
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center
        • Principal Investigator:
          • Mike Rinaldi, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Christ Hospital
        • Principal Investigator:
          • Joseph Choo, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Samir Kapadia, MD
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • Oklahoma Heart Institute
        • Principal Investigator:
          • Kamran Muhammad, MD
    • Oregon
      • Portland, Oregon, United States, 97293
        • Recruiting
        • Oregon Health & Science University
        • Principal Investigator:
          • Scott Chadderdon, MD
        • Principal Investigator:
          • Firas Zahr, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Principal Investigator:
          • Howard Hermann, MD
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Heart Institute
        • Principal Investigator:
          • William Gray, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Colin Barker, MD
        • Principal Investigator:
          • Brian Lindman, MD
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • Saint Thomas Health
        • Principal Investigator:
          • Michael Morse, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas health Science Center at Houston
        • Principal Investigator:
          • Abhijeet Dhoble, MD
      • Houston, Texas, United States, 77004
        • Recruiting
        • HCA Houston Healthcare
        • Principal Investigator:
          • Pranav Loyalka, MD
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Heart Hopsital Plano
        • Principal Investigator:
          • Robert Smith, MD
        • Principal Investigator:
          • Molly Szerlip, MD
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Principal Investigator:
          • Brian Whisenant, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System
        • Principal Investigator:
          • Scott Lim, MD
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Hospital
        • Principal Investigator:
          • Paul Mahoney, MD
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • James McCabe, MD
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center
        • Principal Investigator:
          • Sameer Gafoor, MD
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Virginia Mason Franciscan Health
        • Principal Investigator:
          • Ming Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Experimental: Continued Access Study
Provides continued access to 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 6 months
Comparison of number of participants with reduction in TR and composite endpoint event improvement between experimental and active comparator arms
6 months
Rate of Major Adverse Events (MAE)
Time Frame: 30 days
Rate of Major Adverse Events (MAE) in experimental arm
30 days
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
Time Frame: 1 year
Comparison of number of participants with composite endpoint events between experimental and active comparator arms
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 1 year
Hierarchical comparison of number of participants with composite endpoint events between experimental and active comparator arms
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Rebecca Hahn, MD, Columbia University
  • Principal Investigator: Philipp Lurz, MD, Herzzentrum Leipzig GmbH
  • Principal Investigator: Vinod Thourani, MD, Piedmont Heart Institute
  • Principal Investigator: Susheel Kodali, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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