Edwards PASCAL TrAnScatheter Mitral Valve RePair System Pivotal Clinical Trial (CLASP IID): A prospective multicenter randomized controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Mitral Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR)

Are you eligible to participate in this study?

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

  • Conditions:
    Degenerative Mitral Regurgitation
  • Age: Between 18 - 110 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects are 18 years or older
    2. Subjects are able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit compliance
    3. Subjects determined to be at prohibitive risk for mitral valve surgery by a heart team
    4. Subjects determined to be a candidate for transcatheter mitral valve repair by a heart team for both PASCAL and MitraClip; OR patient is determined to be a candidate for PASCAL but not MitraClip due to valve anatomy
    5. Subjects deemed a candidate for transseptal catheterization by the site interventional operation

You may not be eligible for this study if the following are true:

    1. Subjects with a TEE is contraindicated or screening TEE is unsuccessful
    2. Subjects with mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
    3. Subjects with mitral valve orifice area < 4.0 cm2
    4. Subjects with echocardiographic evidence of intracardiac mass, thrombus, or vegetation OR Echocardiographic evidence of severe right ventricular dysfunction per core lab assessment
    5. Subjects with end-stage Heart Failure with inotrope support or consideration for LVAD or heart transplant
    6. Subjects who have clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction
    7. Subjects who had stroke within 90 days
    8. Subjects with other severe valve disorders requiring intervention or left ventricular outflow obstruction
    9. Subjects with infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
    10. Subjects with bradycardia with heart rate <45 bpm (unless treated with a permanent pacemaker) or uncontrolled tachyarrhythmias
    11. Subjects with any recent percutaneous coronary, carotid, endovascular intervention, carotid surgery, or cardiac surgery
    12. Subjects with recent implant or revision of any rhythm management device



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