Edwards CLASP TR EFS

Study Overview
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Brief Summary
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Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation

Detailed Description
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The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System

Official Title
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Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study

Conditions
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Tricuspid Regurgitation

Intervention / Treatment
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* Device: Edwards PASCAL Transcatheter Valve Repair System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe functional or degenerative TR Symptomatic despite medical therapy The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair Exclusion Criteria: Unsuitable anatomy Previous tricuspid valve repair or replacement Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the 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<br>Treatment with the Edwards PASCAL Transcatheter Valve Repair System | Device: Edwards PASCAL Transcatheter Valve Repair System<br>* Repair of the 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 |
| --- | --- | --- |
| Freedom from device or procedure-related adverse events | Safety assessed by 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, 1 year | 
| Reduction in TR grade | Number of patients with reduction in TR from baseline | 30 days, 3 Months ,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, 1 year | 
| 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, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional, TR, FTR, Transcatheter, Repair, Regurgitation, Degenerative