Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective multicenter randomized controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASC

Are you eligible to participate in this study?

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

  • Conditions:
    Mitral Valve Regurgitation
  • Age: Between 18 - 110 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    CLASP IID Cohort:
    1. Participants who are minimum of 18 years of age and able to provide informed consent
    2. Those at prohibitive risk for mitral valve surgery by a heart team
    3. A candidate for transcatheter mitral valve repair by a heart team for both the PASCAL System and the MitraClip System; OR for the PASCAL System but not the MitraClip System due to valve anatomy
    4. A candidate for transseptal catheterization
    5. Mitral regurgitation (3+ to 4+) by echo (TTE or TEE)
    6. Suitable valve and regurgitant jet morphology by TEE
    7. Left ventricular ejection fraction (LVEF) = 20%
    8. LVEDD = 80mm by TTE
    CLASP IIF Cohort:
    1. Participants who are minimum of 18 years of age and able to provide informed consent
    2. Those at prohibitive risk for mitral valve surgery by a heart team
    3. Mitral regurgitation(MR =3+) by echo (TTE or TEE)
    4. Left ventricular ejection fraction (LVEF) = 20% and =50%
    5. Left Ventricular End Systolic Dimension (LVESD) is =70 mm
    6. LVEDD = 80mm by TTE
    7. Stable heart failure medications
    8. A candidate for Transseptal catheterization
    9. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV

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

  • CLASP IID Cohort:
    1. Those for who a TEE is contraindicated or screening TEE is unsuccessful
    2. Mitral valve anatomy which may preclude proper PASCAL System or MitraClip System access, use and/or deployment or sufficient reduction in mitral regurgitation for the randomized cohort such as:
      • Evidence of moderate to severe calcification in the grasping area
      • Evidence of severe bi-leaflet/multi scallop prolapse involvement
      • Presence of significant cleft or perforation in the grasping area
      • Leaflet mobility length < 8mm
      • Presence of two or more independent significant jets
      • Presence of one significant jet in the commissural area
    3. Mitral valve orifice area < 4.0 cm2
    4. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
    5. Echocardiographic evidence of severe right ventricular dysfunction per core lab assessment
    6. refractory heart failure requiring advanced intervention
    7. Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction
    8. Recent stroke or has infiltrative cardiomyopathies
    9. Any other medical, social, or psychological conditions which may interfere with the participation and completion of the study procedures.
    10. Pregnant or lactating
    CLASP IIF Cohort:
    1. Primarily degenerative MR
    2. Those for who a TEE is contraindicated or screening TEE is unsuccessful
    3. Mitral valve anatomy which may preclude proper PASCAL System or MitraClip System access, use and/or deployment or sufficient reduction in mitral regurgitation for the randomized cohort such as:
      • Insufficient mobile leaflet available for grasping the PASCAL or MitraClip System
      • Evidence of moderate to severe calcification in the grasping area
      • Presence of a significant cleft or perforation in the grasping area
      • Lack of both primary and secondary chordal support in the grasping area
      • Leaflet mobility <8 mm
    4. Mitral valve orifice area < 4.0 cm2
    5. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
    6. Echocardiographic evidence of severe right ventricular dysfunction per core lab assessment
    7. Refractory heart failure requiring advanced intervention
    8. Recent stroke
    9. Bradycardia with heart rate <45 bpm
    10. Any percutaneous coronary, carotid, endovascular intervention, carotid surgery, or cardiac surgery
    11. Pregnant or lactating
    12. Any other medical, social, or psychological conditions which may interfere with the participation and completion of the study procedures.



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