TTVR STRONG Under Coverage With Evidence Development (CED) Study

Last updated: March 27, 2025
Sponsor: Edwards Lifesciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Treatment

EVOQUE

Clinical Study ID

NCT06833476
EVOQUE CED
  • Ages > 65
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

Medicare eligible patients who have received an EVOQUE device or are EVOQUE eligible and have at least severe Tricuspid Regurgitation

Exclusion

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

Study Design

Total Participants: 2044
Treatment Group(s): 1
Primary Treatment: EVOQUE
Phase:
Study Start date:
March 19, 2025
Estimated Completion Date:
December 31, 2032

Study Description

This is a retrospective, non-randomized cohort study measuring 2-year effectiveness of the EVOQUE Transcatheter Tricuspid Valve Replacement (TTVR) system in the real-world.

This study will retrospectively evaluate EVOQUE treated patients in the STS/ACC TVT Registry who have at least severe Tricuspid Regurgitation and can be deterministically linked with Medicare data.

This group will be compared to Medicare eligible and EVOQUE eligible patients evaluated in a standard of care setting from a commercial claims database linked with electronic health records.

We will evaluate the primary outcome measure in various subgroups.

There will be continued access enrollment after the primary completion date.

Connect with a study center

  • Edwards Lifesciences

    Irvine, California 92614
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.