The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

Inclusion Criteria: * Signed and dated IRB/ethics committee approved study consent form prior to study related procedures * Eighteen (18) years of age or older * New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy * Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation * Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE). * The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant. * Mitral valve area (MVA) ≥ 4.0 cm² as measured by planimetry. If MVA by planimetry is not measurable, pressure half-time measurement is acceptable. Exclusion Criteria: * Patient in whom a TEE is contraindicated or screening TEE is unsuccessful * Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation. * Mitral valve area (MVA) \< 4.0 cm² as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable) * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation * Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction * Concurrent medical condition with a life expectancy of less than 12 month…