Active — Not RecruitingNot Applicable

TRISCEND JAPAN Study

Japan45 participantsStarted 2023-02-06

Plain-language summary

A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe tricuspid regurgitation despite medical therapy. Subjects will be followed at discharge, 30 days, 6 months and annually through 5 years.

Who can participate

Age range18 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: * Symptomatic tricuspid regurgitation (TR) despite medical therapy * TR graded as severe or greater * Appropriate for transcatheter tricuspid valve replacement per the local heart team 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

What they're measuring

All-Cause Mortality

Timeframe: 1 year

Heart Failure Hospitalization

Timeframe: 1 year

Trial details

NCT IDNCT05760989

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Tricuspid Valve Regurgitation trials