Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System

Study Overview
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Brief Summary
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This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid valve repair.

Detailed Description
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The objectives of this clinical study are to collect data on the safety and effectiveness of the PASCAL System and PASCAL Precision System in improving TR, functional status, and quality of life in a post-market setting.

Official Title
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Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-Market Clinical Follow up

Conditions
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Tricuspid Valve Insufficiency

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is a candidate for transcatheter tricuspid valve repair as determined by a Heart Team TR grade ≥3+ (5 grade classification) Patient is eligible to receive the PASCAL device per the current approved indications for use Exclusion Criteria: Tricuspid valve anatomic contraindications, including previous tricuspid valve replacement Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator Any patient considered to be part of a vulnerable population

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Edwards PASCAL Transcatheter Valve Repair System|The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.|
|Device: Edwards PASCAL Precision Transcatheter Valve Repair System|The Edwards PASCAL Precision Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with major adverse events (MAE rates) | The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days | 30 days | 
| Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography | Reduction in TR severity as assessed by TEE pre and post-implant in the procedure room. TR severity compared to baseline will be assessed by TR grade at each follow-up interval. | Discharge: defined as discharge or 7 days post-procedure, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume overload assessed by serial measurements | Patient edema questionnaire | baseline, 30 days, 6 months, 12 months, annually up to 5 years | 
| Volume overload assessed by serial measurements | Body weight in kilogram | baseline, 30 days, 6 months, 12 months, annually up to 5 years | 
| Volume overload assessed by serial measurements | Edema Assessment (scale 1+ - 4+) grade correspond to mm | baseline, 30 days, 6 months, 12 months, annually up to 5 years | 
| Volume overload assessed by serial measurements | Ankle circumference measurement in cm | baseline, 30 days, 6 months, 12 months, annually up to 5 years | 
| Functional class, functional status, and Quality of life as assessed | NYHA classification (I-IV) grade | baseline, 30 days, 6 months, 12 months, annually up to 5 years | 
| Functional class, functional status, and Quality of life as assessed | 6-Minute Walk Test in meter | baseline, 30 days, 6 months, 12 months, annually up to 5 years | 
| Functional class, functional status, and Quality of life as assessed | 5 Level EQ 5D Questionnaire | baseline, 30 days, 6 months, 12 months, annually up to 5 years | 
| Functional class, functional status, and Quality of life as assessed | Kansas City Cardiomyopathy Questionnaire | baseline, 30 days, 6 months, 12 months, annually up to 5 years |