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Clinical Trials in the USA / NCT04221490
Active, not recruiting Not applicable

2019-06 TRISCEND Study

NCT04221490 · tracked via the Priya Life Science USA tracker
Sponsor
Edwards Lifesciences
Phase
Not applicable
Started
2020-05-06
Last updated
2026-05-08

Condition(s) studied

Tricuspid Valve RegurgitationHeart Valve DiseasesCardiovascular Diseases

Investigational drug(s) / intervention(s)

Transcatheter Tricuspid Valve Replacement

Transcatheter Tricuspid Valve Replacement: Replacement of the tricuspid valve through a transcatheter approach

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite Major Adverse Events (MAEs) — 30 Days
    Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency tricuspid valve re-intervention, major access site and vascular complications, major access site and vascular complications, and device-related pulmonary embolism at 30 days.
  • Device Success — Intraprocedural
    Study device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.
  • Procedure Success — Discharge (Up to 7 days post procedure)
    Device success without clinically significant paravalvular leak (PVL) on a transthoracic echocardiogram (assessed by the echo core lab) at time of discharge.
  • Clinical Success — 30 Days
    Procedural success without MAEs at 30 days.
  • Tricuspid Regurgitation Reduction — Discharge (Up to 7 days post procedure)
    Percentage of patients with at least 1 grade reduction in tricuspid regurgitation (TR) as measured by using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory.

Trial sites (20)

FacilityCityRegionStatus
Cedars-Sinai Medical Center Los Angeles California
Stanford University Stanford California
Emory University Atlanta Georgia
Piedmont Heart Institute Atlanta Georgia
Northwestern University Evanston Illinois
Massachusetts General Hospital Boston Boston Massachusetts
Brigham and Women's Hospital Boston Massachusetts
Henry Ford Hospital Detroit Michigan
Columbia University Irving Medical Center / NYPH New York New York
Montefiore Medical Center The Bronx New York
Oregon Health & Science University Portland Oregon
Hospital of the University of Pennsylvania Philadelphia Pennsylvania
Baylor Heart Hopsital Plano Plano Texas
University of Virginia Health System Charlottesville Virginia
St. Paul's Hospital Vancouver Vancouver British Columbia
St. Michael's Hospital Toronto Ontario
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval) Québec Canada
CHU Bordeaux, Hôpital Cardiologique Haut Lévêque Pessac France
Clinique Pasteur Toulouse France
InselSpital University Hospital Bern Bern Switzerland

More Edwards Lifesciences trials in the USA

ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Active, not recruiting
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study) Recruiting
PARTNER 3 Trial - Aortic Valve-in-Valve Recruiting
COMPASSION S3 Post-Approval Study Active, not recruiting
ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System Active, not recruiting

Other trials for the same condition

VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial) Recruiting
Global Paradise System US Post Approval Study Recruiting
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study) Recruiting
RADIANCE Continued Access Protocol Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04221490 on ClinicalTrials.gov ↗ ← All trials in the USA