N/A
Completed N=220
Edwards PASCAL Transcatheter Valve Repair System Registry
Mitral Valve Insufficiency
Source: ClinicalTrials.gov NCT04443218 ↗
Enrolled (actual)
220
Serious AEs
37.3%
Results posted
Jul 2024
Primary outcomePrimary: Major Adverse Events (MAEs) — 9; 2; 0; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Events (MAEs) |
9; 2; 0; 1; 5; 2 | — |
| PRIMARY Mitral Regurgitation (MR) Reduction to <=2+ |
155; 122 | — |
| SECONDARY Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores |
45.3; 59.1; 71.0 | — |
| SECONDARY Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS) |
51.9; 60.6; 61.6 | — |
| SECONDARY New York Heart Association (NYHA) Functional Classification |
3; 33; 161; 19; 29; 89 | — |
| SECONDARY 6-Minute Walk Test (6MWT) |
275.5; 292.9; 310.2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04443218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.