TRISCEND JAPAN Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Device: Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic tricuspid regurgitation (TR) despite medical therapy TR graded as severe or greater Appropriate for transcatheter tricuspid valve replacement per the local heart team Exclusion Criteria: Tricuspid valve anatomic contraindications Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months Hemodynamic instability Refractory heart failure requiring advanced intervention Currently participating in another investigational study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with the Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System<br> | Device: Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System<br>* Replacement of the native tricuspid valve through a transcatheter approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter, Tricuspid Disease, Valve Replacement, Tricuspid Valve