2019-06 TRISCEND Study

Study Overview
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Brief Summary
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Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Detailed Description
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The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System.

Official Title
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Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device

Conditions
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Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Device: Transcatheter Tricuspid Valve Replacement


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Functional or degenerative TR moderate or greater Symptomatic despite medical therapy or prior HF hospitalization from TR The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement Key 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 in which the patient has not reached a primary endpoint

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<br>Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System | Device: Transcatheter Tricuspid Valve Replacement<br>* Replacement of the tricuspid valve through a transcatheter approach<br>* Other names: Edwards EVOQUE Tricuspid Valve Replacement System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device or procedure-related adverse events [Time Frame: 30 days] | Freedom from device or procedure-related adverse events | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA Functional Class | Number of patients with improvement in NYHA class | 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 | 
| Reduction in TR grade | Number of patients with reduction in TR from baseline | 30 days, 6 months, 12 months, annual for five years | 
| Health Status - KCCQ | Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire | 30 days, 6 months, 12 months, annual for five years | 
| Health Status - SF-36 | 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 | 

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