TRISCEND JAPAN Study

Conditions: Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: NA

Enrollment: 53

Sponsor: Edwards Lifesciences

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05760989). StuddyBuddy aggregates publicly available trial information.