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TRISCEND JAPAN Study
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.
Official title: Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System: Investigation of Safety and Clinical Efficacy Using a Novel Device in Patients With at Least Severe Tricuspid Regurgitation in JAPAN
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2023-02-06
Completion Date
2029-09-30
Last Updated
2024-08-28
Healthy Volunteers
No
Interventions
Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
Replacement of the native tricuspid valve through a transcatheter approach
Locations (8)
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Osaka Keisatsu Hospital
Osaka, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
National Cerebral and Cardiovascular Center
Suita-shi, Osaka, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, Japan