Percutaneous Mitral Valve Repair – Continued Access Registry for the Evalve Inc. MitraClip system for patients with 3+/4+ mitral regurgitation. (REALISM)

Continued Access Registry for the Evalve Inc. MitraClip system for patients with 3+/4+ mitral regurgitation.

Heart & Vascular - Structural Heart Trials
Mark Reisman, MD

Key Inclusion Criteria:

  • Symptomatic moderate-to-severe or severe MR or
  • Asymptomatic moderate-to-severe or severe MR:
    1. LVEF 25-50 and/or LVESD 50-55
    2. LVEF 50-60 and LVESD <45
    3. LVEF 50-60 and LVESD 45-55
    4. LVEF >60% and LVESD 45-55 or
    5. Pulmonary HTN defined as PASP >50 mmHg at rest or >60mmHg with exercise
  • Candidate for MR surgery including cardiopulmonary bypass
  • Transseptal catheterization is determined to be feasible by treating physician

Key Exclusion Criteria:

  • Severe left ventricular dysfunction, defined as less than or equal to 25% and/or end-systolic dimension >55mm
  • Intervention within 30 days of the index procedure
  • If leaflet flail is present, the flail gap is greater than or equal to 10mm and the flail width is greater...
Structural Heart Trials
(206) 215-1500
(206) 560-0889