TTVR STRONG Under Coverage With Evidence Development (CED) Study

NCT06833476 · tracked via the Priya Life Science USA tracker

Sponsor

Edwards Lifesciences

Phase

Observational

Started

2025-03-19

Last updated

2025-03-28

Condition(s) studied

Tricuspid Regurgitation

Investigational drug(s) / intervention(s)

EVOQUE

EVOQUE: This is a retrospective, non-randomized study. The decision to intervene by TTVR with the EVOQUE device is made by the heart team.

Study summary

This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement procedure using the EVOQUE system.

Eligibility

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Medicare eligible patients who have received an EVOQUE device or are EVOQUE eligible and have at least severe Tricuspid Regurgitation Exclusion Criteria: Commercially insured patients who have received an EVOQUE device or are EVOQUE eligible or Medicare eligible patients with less than severe Tricuspid Regurgitation

Primary outcome measure(s)

Composite (All-Cause Death or Heart Failure Hospitalization) — 2 years
Time to death or heart failure hospitalization after time zero

Trial sites (1)

Facility	City	Region	Status
Edwards Lifesciences	Irvine	California	Recruiting

More Edwards Lifesciences trials in the USA

ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System Active, not recruiting

Autus Valve Pivotal Study Active, not recruiting

COMPASSION S3 Post-Approval Study Active, not recruiting

SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation Active, not recruiting

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent Active, not recruiting

Other trials for the same condition

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial Recruiting

Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study Recruiting

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US) Recruiting

Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System Recruiting

TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I) 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 NCT06833476 on ClinicalTrials.gov ↗ ← All trials in the USA