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NCT03170349 · ClinicalTrials.gov registry record · NA
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
A NA study, sponsored by Edwards Lifesciences.
- Completed
- Registry status
- NA
- Development phase
- 124
- Enrollment target
NCT03170349: Completed NA study, sponsored by Edwards Lifesciences.
NCT03170349 is a NA study that has completed, run by Edwards Lifesciences. The registered enrollment target is 124 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03170349, a NA study, has completed, sponsored by Edwards Lifesciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 124 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.
Primary Outcome
Composite of major adverse events (MAE) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 30 days post-implant. MAEs during the first year of post-implant follow-up were adjudicated by a Clinical Events Committee of independent heart specialist physicians.
Interventions
- DEVICE Mitral Valve Repair
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2017-06-27 |
| Est. Completion | 2025-05-27 |
| Phase | NA |
What the finished NCT03170349 record still lists
NCT03170349 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Mitral Valve Repair is the first listed.
NCT03170349 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03170349 about?
NCT03170349 is a clinical study titled "The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study". The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.
What is the current status of trial NCT03170349?
This trial is currently completed. It is a NA study. The enrollment target is 124 participants. The study started on 2017-06-27. Estimated completion is 2025-05-27.
What interventions are being tested in trial NCT03170349?
The interventions under investigation include: Mitral Valve Repair (DEVICE).
Who is sponsoring clinical trial NCT03170349?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03170349's enrollment target sits among peer trials
124 758th of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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