Percutaneous mitral valve repair for mitral insufficiency – EVEREST II

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

Type of Study
Heart & Vascular - Structural Heart Trials
Short Description

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

Status
Open
Principal Investigator
Mark Reisman, MD
Eligibility Notes

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 than or equal to 15mm
  • Coaptation depth is more than 11mm or coaptation length is less than 2mm
  • Severe mitral annular calcification
  • Mitral valve orfice area <4.0 cm2
  • Prior mitral valve surgery or valvuloplasty or currently implanted mechanical prosthetic valve or currently implanted VAD
  • Systolic pressure <90 mmHg w/out afterload reduction, cardiogenic shock, need for inotropic support or intra-aortic balloon pump
  • Systolic anterior motion of the mitral valve leaflet
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • Endocarditis
  • Hypertrophic cardiomyopathy
  • History of or active rheumatic heart disease
  • History of ASD, repaired or not
  • History of PFO associated with clinical symptoms (e.g., cerebral ischemia) or previously repaired or when atrial septal aneurysm is present
  • Upper GI bleeding within the prior 6 months

Follow-up:

  • Clinic Visits at 30 days (with TTE, ECG, and blood work), 6 months (with TTE, ECG, and blood work) and 1-5 years (with TTE, ECG, and blood work)
Phone
(206) 215-1500
Alternate Phone
(206) 560-0889