Trials / Active Not Recruiting
Active Not RecruitingNCT03706833
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,247 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Detailed description
A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT) Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
Conditions
- Degenerative Mitral Valve Disease
- Mitral Regurgitation
- Mitral Insufficiency
- Functional Mitral Regurgitation
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards PASCAL System | Transcatheter mitral valve repair with the Edwards PASCAL System |
| DEVICE | Abbott Mitraclip System | Transcatheter mitral valve repair with the Abbott Mitraclip System |
Timeline
- Start date
- 2018-11-30
- Primary completion
- 2026-06-30
- Completion
- 2031-06-30
- First posted
- 2018-10-16
- Last updated
- 2026-04-09
Locations
86 sites across 4 countries: United States, Canada, Germany, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03706833. Inclusion in this directory is not an endorsement.