IRB Study Number 19-241
Status Recruiting
Phase Phase 3
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The purpose of this study is to determine the safety and performance of the Edwards PASCAL Transcatheter Mitral Valve Repair System (PASCAL System) compared to the Abbott MitraClip Transcatheter Mitral Valve Repair System (MitraClip System) in patients with symptomatic degenerative mitral regurgitation (DMR) who are at high-operative risk for mitral valve surgery.
Inclusion Criteria
Eighteen (18) years of age or older
Mitral regurgitation (3+ to 4+) by echo
Patient is determined to be at prohibitive risk for mitral valve surgery by a heart team
Exclusion Criteria
Mitral valve anatomy which does not qualify for proper Pascal CLASP or Mitraclip use
