Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry With the Edwards PASCAL Transcatheter Valve Repair System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Valve Insufficiency
- Sponsor
- Edwards Lifesciences
- Enrollment
- 220
- Locations
- 14
- Primary Endpoint
- Major Adverse Events (MAEs)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Major Adverse Events (MAEs)
Time Frame: 30 days
Composite rate of all-cause death, myocardial infarction, stroke, heart failure hospitalization, or complication requiring transcatheter or surgical intervention (repeat transcatheter edge-to-edge repair \[TEER\] or mitral valve surgery)
Mitral Regurgitation (MR) Reduction to <=2+
Time Frame: 30 days, 12 months
MR severity assessed by sites using a 5-grade scale: none/trace (0-1+), mild (1+), mild to moderate (2+), moderate to severe (3+), and severe (4+).
Secondary Outcomes
- 6-Minute Walk Test (6MWT)(Baseline, 30 days, 12 months)
- New York Heart Association (NYHA) Functional Classification(Baseline, 30 days, 12 months)
- Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores(Baseline, 30 days, 12 months)
- Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)(Baseline, 30 days, 12 months)