CLASP IID/IIF

Conditions studied

Degenerative Mitral Valve Disease, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Regurgitation

What is being tested

• DEVICE: Abbott Mitraclip System
• DEVICE: Edwards PASCAL System

What it measures

• PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs)., 30 days.
• PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort., 6 months
• PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only., From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up