The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

Edwards Lifesciences

Status

Completed

Conditions

Mitral Valve Regurgitation

Treatments

Device: Mitral Valve Repair

Study type

Interventional

Funder types

Industry

Identifiers

NCT03170349

2016-05

Details and patient eligibility

About

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

Full description

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.

Enrollment

124 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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