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The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study (NCT03170349)

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.
  • Device: Mitral Valve Repair
    Minimal Invasive Transcatheter Mitral Valve Repair
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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
    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.

    8 locations

    Status:
    recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    26 June, 2017
    Updated:
    14 December, 2017
    Participants:
    120
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