Edwards PASCAL Transcatheter Valve Repair System Registry

Study Overview
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Brief Summary
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This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post Market Clinical Follow-up (PMCF) study.

Detailed Description
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Patients treated per standard of care at their medical facilities and a written informed consent will be collected to allow the data to be collected. This registry intends to enroll patients under commercial usage and will serve as a mechanism to collect clinical data to further characterize the safety, performance and effectiveness of the PASCAL Transcatheter Valve Repair System.

Official Title
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Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry With the Edwards PASCAL Transcatheter Valve Repair System

Conditions
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Mitral Valve Insufficiency

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: Patient signs informed consent to participate in the registry Patient is intended to or has received the PASCAL device Exclusion Criteria: Patient does not consent to participate Patient is part of an ongoing Edwards Pre or Post Market Clinical study for the PASCAL Transcatheter Valve Repair System.

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 mitral valve.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events (MAEs) | Rates of Major Adverse Events (MAE) at 30 days. | 30 days | 
| Mitral Regurgitation Change | Change in severity of mitral regurgitation | 30 days | 
| Mitral Regurgitation Change | Change in severity of mitral regurgitation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life - KCCQ | Change in Quality of Life as assessed by KCCQ | 30 days | 
| Change in Quality of Life - KCCQ | Change in Quality of Life as assessed by KCCQ | 12 months | 
| Change in Quality of Life - EuroQol Group EQ-5D | Change in Quality of Life as assessed by EuroQol Group EQ-5D | 30 days | 
| Change in Quality of Life - EuroQol Group EQ-5D | CHange in Quality of Life as assessed by EuroQol Group EQ-5D | 12 months | 
| New York Heart Association scale | Change in NYHA scale rated from I-IV | 30 days | 
| New York Heart Association scale | Change in NYHA scale rated from I-IV | 12 months | 
| 6 Minute Walk test | Change in distance in meters in the 6 minute walk test | 30 days | 
| 6 Minute Walk test | Change in distance in meters in the 6 minute walk test | 12 months |