The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. This is a multi-center, multi-national, prospective, single arm, safety, performance and clinical outcomes 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 months in the judgment of the Investigator
• Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment
• Patient is under guardianship