Last updated on June 2009

VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Heart Failure | Ischemic Heart Disease | Mitral Incompetence | Mitral Valve Regurgitation | Left Ventricular Dysfunction | Mitral Insufficiency
  • Age: Between 18 - 85 Years
  • Gender: Male or Female
  • Other:
    Key Inclusion Criteria:
    Grade 3 or 4 functional mitral valve regurgitation per 2D echocardiography.
    NYHA Class II and LVEF greater than or equal to 25% or NYHA Class III and LVEF
    greater than or equal to 30%
    Key Exclusion Criteria:
    History of pericarditis.
    Creatinine > 2.2 at the time of the procedure
    INR > 1.8 at the time of the procedure
    Prior pericardial intervention (including CABG, pericardiotomy or
    pericardiocentesis).
    Any endovascular therapeutic interventional or surgical procedure performed within 30
    days prior to the index procedure (e.g., stent placement).
    Any planned therapeutic interventional or surgical procedure planned within 30 days
    following the index procedure
    Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis,
    myocarditis).
    Structural abnormality of the mitral valve
    Valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or
    tricuspid valve requiring intervention.
    Pericardial effusion >5 mm via echocardiography.
    Posterior wall end-diastolic dimension >1.3 cm.
    Left ventricular end diastolic diameter > 7.0 cm.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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