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. 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