IRB Study Number 19-241
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
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.
Inclusion Criteria
- Patient is determined to be at prohibitive risk for mitral valve surgery by a heart team
- Patient is determined to be a candidate for transcatheter mitral valve repair by a heart team for both the PASCAL System and the MitraClip System
- Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow‐up visit compliance
- Other Inclusion Criteria will be assessed by study personnel.
Exclusion Criteria
- Mitral valve anatomy which might limit proper PASCAL System or MitraClip System access, use and/or deployment or sufficient reduction in mitral regurgitation
- Patient in whom a TEE is contraindicated, or screening TEE is unsuccessful
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Other Exclusion Criteria will be assessed by study personnel.
