Clinical Trial

TRISCEND JAPAN Study

Study acronym: TRISCEND JAPAN
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated August 28, 2024 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-02-27; most recent amendment 2024-08-27.
Status change: Recruiting → Active, Not Recruiting 2024-08-27
Trial Details
NCT Number NCT05760989
Lead Sponsor Edwards Lifesciences
Conditions Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
Enrollment 45 participants
Start Date 2023-02-06
Primary Completion 2025-09-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-08-28