Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- Degenerative Mitral Valve Disease
- Functional Mitral Regurgitation
- Mitral Insufficiency
- Mitral Regurgitation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03706833
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Scott Lim, MD University of Virginia Principal Investigator: Robert Smith, MD The Heart Hospital Baylor Plano Principal Investigator: Linda Gillam, MD Morristown Medical Center Principal Investigator: Vinod Thourani, MD Piedmont Healthcare Principal Investigator: Paul Grayburn, MD The Heart Hospital Baylor Plano Principal Investigator: Brian K Whisenant, MD Intermountain Medical Center
Get Well Soon