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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 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 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 heart failure de-spite optimal medical therapy
    • Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
    • Patient able to perform a six-minute walk test (6MWT).
    • 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.
    • Subject agrees to return for all required post-procedure follow-up visits
    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.
    • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
    • Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction
    • Untreated significant coronary artery disease / stenosis, evidence of acute coronary syndrome, myocardial infarction, transient ischemic attack or stroke within 30 days prior to intervention
    • Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery or atrial fibrillation ablation within 90 days prior to intervention
    • Any prior mitral valve surgery or transcatheter mitral valve procedure
    • Contraindication to transseptal catheterization
    • Active endocarditis or active infections requiring current antibiotic therapy or last antibiotic treatment was administered within 14 days prior to intervention
    • Active rheumatic heart disease or rheumatic etiology for MR
    The purpose of this study is to assess the safety and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. This is a multi-center, multi-national, prospective, single arm, safety and clinical outcomes study.

    5 locations

    Status:
    recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    26 June, 2017
    Updated:
    06 September, 2017
    Participants:
    130
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