At a glance
ClinicalIndex Comparison RecordN/ACompleted· 220 enrolled
Drug / intervention
Edwards PASCAL Transcatheter Valve Repair Systemdevice
Likely dose
Edwards PASCAL Transcatheter Valve Repair System (device-based intervention; no dose applicable)AI-extracted
Key inclusion· 2
- ✓Patient has received or is intended to receive the Edwards PASCAL transcatheter valve repair device
- ✓Patient provides informed consent to participate in the registry
Key exclusion· 1
- ✕Patient is enrolled in an ongoing Edwards pre-market or post-market clinical trial for the PASCAL device
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry With the Edwards PASCAL Transcatheter Valve Repair System
In Brief
An observational study evaluating Edwards PASCAL Transcatheter Valve Repair System for Mitral Valve Insufficiency. Completed, enrolled 220 participants across 14 sites in 2 countries.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Valve Insufficiency
CountriesGermany, Switzerland
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
Enrollment StartMay 2019
First PostedJun 2020
Primary CompletionMay 2021
TodayJul 2026
First PostedJun 23, 2020
Enrollment StartMay 27, 2019
Primary CompletionMay 10, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.0 years ago
Interventions
Edwards PASCAL Transcatheter Valve Repair Systemdevice
The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient mitral valve.