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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Replacement of the native tricuspid valve through a transcatheter approach
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
All-Cause Mortality
Participants with all-cause mortality at 1 year from the index procedure
Time frame: 1 year
Heart Failure Hospitalization
Participants with a heart failure hospitalization at 1 year from the index procedure
Time frame: 1 year
Rates of various adverse events
Rates of various adverse events as defined in the protocol
Time frame: 30 days, 6 months, 12 months, annual for five years
Rate of Major Adverse Events (MAEs)
Composite rate of MAEs as defined in the protocol
Time frame: 30 days
Reduction in TR grade
Number of participants with reduction in TR from baseline
Time frame: 30 days, 6 months, 12 months, annual for five years
New York Heart Association (NYHA) Functional Class
Number of participants with improvement in NYHA class
Time frame: 30 days, 6 months, 12 months, annual for five years
Health Status as measured by the SF-36 Questionnaire
Number of points of improvement in health status as measured by 36-item short form survey (SF-36)
Time frame: 30 days, 6 months, 12 months, annual for five years
Health Status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Number of points of improvement in health status as measured by KCCQ
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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
Time frame: 30 days, 6 months, 12 months, annual for five years
Health Status as measured by the EQ-5D-5L Questionnaire
Number of points of improvement in health status as measured by EQ-5D-5L Questionnaire
Time frame: 30 days, 6 months, 12 months, annual for five years
Six-minute walk test
Change in distance (m) from baseline
Time frame: 30 days, 6 months, 12 months, annual for five years