RecruitingNot Applicable

TTVR STRONG Under Coverage With Evidence Development (CED) Study

United States2,044 participantsStarted 2025-03-19

Plain-language 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.

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Composite (All-Cause Death or Heart Failure Hospitalization)

Timeframe: 2 years

Trial details

NCT IDNCT06833476

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12-30

Contact for this trial

TMTT GHER

949-250-3849 TMTT_GHER_EVIDENCE@edwards.com

View on ClinicalTrials.gov More Tricuspid Regurgitation trials