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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with the Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System | Device | Replacement of the native tricuspid valve through a transcatheter approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | Participants with all-cause mortality at 1 year from the index procedure | 1 year |
| Heart Failure Hospitalization | Participants with a heart failure hospitalization at 1 year from the index procedure | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of various adverse events | Rates of various adverse events as defined in the protocol | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshihiro Morino, MD | Iwate Medical University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kokura Memorial Hospital | Kitakyushu-shi | Fukuoka | Japan | |||
| Tokai University Hospital |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D006349 | Heart Valve Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
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| 30 days |
| Reduction in TR grade | Number of participants with reduction in TR from baseline | 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 | 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) | 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 | 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 | 30 days, 6 months, 12 months, annual for five years |
| Six-minute walk test | Change in distance (m) from baseline | 30 days, 6 months, 12 months, annual for five years |
| 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 |