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
Status: Active_not_recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Symptomatic tricuspid regurgitation (TR) despite medical therapy
• TR graded as severe or greater
• Appropriate for transcatheter tricuspid valve replacement per the local heart team
Locations
Other Locations
Japan
Tokai University Hospital
Isehara-shi
Kokura Memorial Hospital
Kitakyushu-shi
Osaka Keisatsu Hospital
Osaka
Sendai Kousei Hospital
Sendai
Keio University Hospital
Shinjuku-ku
Tokyo Women's Medical University Hospital
Shinjuku-ku
Osaka University Hospital
Suita
National Cerebral and Cardiovascular Center
Suita-shi
Time Frame
Start Date: 2023-02-06
Completion Date: 2029-09-30
Participants
Target number of participants: 45
Treatments
Experimental: Treatment with the Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences