2019-06 TRISCEND Study

March 29, 2024 updated by: Edwards Lifesciences

Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

228

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

  • Canada
      • Québec, Canada, G1V 4G5
        • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z1Y6
        • St. Paul's Hospital Vancouver
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
  • France
      • Pessac, France, 33600
        • CHU Bordeaux, Hôpital Cardiologique Haut Lévêque
      • Toulouse, France, 31076
        • Clinique Pasteur
  • Switzerland
      • Bern, Switzerland, 3010
        • InselSpital University Hospital Bern
      • Zürich, Switzerland, CH-8091
        • Universitatsspital Zurich
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Stanford, California, United States, 94305
        • Stanford University
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Boston
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center / NYPH
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Texas
      • Plano, Texas, United States, 75093
        • Baylor Heart Hopsital Plano
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 for transcatheter tricuspid valve replacement

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 has not reached a primary endpoint

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
Device: Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Other Names:
  • Edwards EVOQUE Tricuspid Valve Replacement System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from device or procedure-related adverse events [Time Frame: 30 days]
Time Frame: 30 days
Freedom from device or procedure-related adverse events
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NYHA Functional Class
Time Frame: 30 days, 6 months, 12 months, annual for five years
Number of patients with improvement in NYHA class
30 days, 6 months, 12 months, annual for five years
Six minute walk test
Time Frame: 30 days, 6 months, 12 months, annual for five years
Change in distance (m) from baseline
30 days, 6 months, 12 months, annual for five years
Reduction in TR grade
Time Frame: 30 days, 6 months, 12 months, annual for five years
Number of patients with reduction in TR from baseline
30 days, 6 months, 12 months, annual for five years
Health Status - KCCQ
Time Frame: 30 days, 6 months, 12 months, annual for five years
Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire
30 days, 6 months, 12 months, annual for five years
Health Status - SF-36
Time Frame: 30 days, 6 months, 12 months, annual for five years
Number of points of improvement in health status as measured by 36 item short form survey (SF-36)
30 days, 6 months, 12 months, annual for five years

Collaborators and Investigators

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

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Susheel Kodali, MD, Columbia University

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)

May 6, 2020

Primary Completion (Actual)

January 5, 2024

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 6, 2020

First Posted (Actual)

January 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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