Study ID: CLASP IID/IIF
Edwards PASCAL transcatheter valve repair system pivotal clinical trial
This study seeks to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System vs. Abbott MitraClip in patients with mitral regurgitation (MR). MR is when blood moves backward through the mitral valve each time the left heart ventricle contracts.
All participants undergo transcatheter mitral valve repair. For one group, the physician will use the Edwards PASCAL valve repair system. For the other group, the Abbott MitraClip is used.
Patients undergo follow-up care at discharge, 30 days, six months and annually through five years.
This multicenter, randomized, controlled, phase III study aims to establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation who are at prohibitive risk for mitral valve surgery, and in patients with functional mitral regurgitation on guideline-directed medical therapy.
The study compares the Edwards PASCAL Transcatheter Valve Repair System to Abbott MitraClip. Participants are randomized 2:1 as follows: Two in CLASP IID/IIF vs. one in the MitraClip study arm.
- Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only)
- Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
- Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
- Mitral regurgitation (3+ to 4+) by echo
- Other inclusion/exclusion criteria apply
Note: Patients who are candidates for the PASCAL System but not the MitraClip System due to valve anatomy may qualify to participate in the single arm PASCAL IID Registry and will not be part of the randomized cohort.
- Must have been diagnosed with either degenerative or functional mitral valve regurgitation
- Must be willing to undergo transcatheter mitral valve repair
- Must have been determined by a physician to be at prohibitive risk for mitral valve surgery