Pivotal Study of a Percutaneous Mitral Valve Repair System (EVEREST II)

• Freedom from surgery for valve dysfunction, death, and moderate to severe (3+) or severe (4+) mitral regurgitation at 12 months (RCT and REALISM non-high risk arm). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• Major adverse events (MAE) (RCT) [ Time Frame: 30 days or hospital discharge, whichever is longer ] [ Designated as safety issue: Yes ]
  
• Mortality (HRR) [ Time Frame: 30 days or hospital discharge, whichever is longer ] [ Designated as safety issue: Yes ]
  

• Major adverse events (HRR, REALISM high risk and non-high risk arms) [ Time Frame: 30 days or hospital discharge, whichever is longer and 12 months. ] [ Designated as safety issue: Yes ]
  
• Major vascular and bleeding complications (RCT, HRR) [ Time Frame: 30 days or hospital discharge, whichever is longer and 12 months ] [ Designated as safety issue: Yes ]
  
• Non-cerebral thromboembolism (RCT and HRR) [ Time Frame: 30 days or hospital discharge, whichever is longer and 12 months ] [ Designated as safety issue: Yes ]
  
• Endocarditis (RCT and HRR) [ Time Frame: 30 days or hospital discharge, whichever is longer and 12 months ] [ Designated as safety issue: Yes ]
  
• Thrombosis (RCT and HRR) [ Time Frame: 30 days or hospital discharge, whichever is longer and 12 months ] [ Designated as safety issue: Yes ]
  
• Hemolysis (RCT and HRR) [ Time Frame: 30 days or hospital discharge, whichever is longer and 12 months ] [ Designated as safety issue: Yes ]
  
• Clinically significant Atrial septal defect (RCT, HRR and REALISM high risk and non-high risk arms) [ Time Frame: 30 days or hospital discharge, whichever is longer and 12 months ] [ Designated as safety issue: Yes ]
  
• Mitral Valve stenosis (RCT, HRR and REALISM high risk and non-high risk arms) [ Time Frame: 30 days or hospital discharge, whichever is longer and 12 months ] [ Designated as safety issue: Yes ]
  
• NYHA functional class (RCT, HRR and REALISM high risk and non-high risk arms) [ Time Frame: 30 days, 6 months and 12 months ] [ Designated as safety issue: Yes ]
  
• Acute procedural success defined as successful MitraClip implantation with resulting MR of 2+ or less (RCT, HRR and REALISM high risk and non-high risk arms) [ Time Frame: Discharge ] [ Designated as safety issue: No ]
  
• Post-procedure length of hospital stay (RCT, HRR and REALISM high risk and non-high risk arms) [ Time Frame: Discharge ] [ Designated as safety issue: No ]
  
• Post-procedure ICU/CCU/PACU duration (RCT, HRR and REALISM high risk and non-high risk arms) [ Time Frame: Discharge ] [ Designated as safety issue: No ]
  
• SF-36 Quality of Life questionnaire (RCT, HRR and REALISM high risk and non-high risk arms) [ Time Frame: 30 days and 12 months ] [ Designated as safety issue: No ]
  
• MAE in patients over 75 years of age (RCT, HRR, REALISM high risk and non-high risk arms) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  
• Mitral valve repair success (RCT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• Procedural success defined as successful implant of the Clip(s) with resulting MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction at 30 days (HRR & REALISM high risk & non-high risk arms) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  
• Freedom from surgery for valve dysfunction, death, and moderate to severe (3+) or severe (4+) mitral regurgitation at 18 and 24 months (RCT) [ Time Frame: 18 and 24 months ] [ Designated as safety issue: No ]
  
• Clip implant rate defined as the rate of successful implantation of MitraClip(s) (RCT, HRR, REALISM high risk and non-high risk arms) [ Time Frame: procedural ] [ Designated as safety issue: No ]
  
• Procedural freedom from MAE (RCT and HRR) [ Time Frame: procedural ] [ Designated as safety issue: Yes ]
  
• Acute surgical success defined as successful mitral valve repair or replacement (RCT) [ Time Frame: Discharge ] [ Designated as safety issue: No ]
  
• Left ventricular volumes and dimensions (RCT, HRR, REALISM high risk and non-high risk arms) [ Time Frame: 30 days and 12 months ] [ Designated as safety issue: No ]
  
• Incidence of hospital readmissions for CHF (HRR and REALISM high risk arm) [ Time Frame: 12 months pre- versus post-MitraClip ] [ Designated as safety issue: No ]
  
• Number of days hospitalized for CHF (HRR and REALISM high risk arm) [ Time Frame: 12 months pre- versus post-MitraClip ] [ Designated as safety issue: No ]
  
• 6 Minute Walk Test (REALISM high risk and non-high risk arms) [ Time Frame: 30 days, 6 months, 12 months ] [ Designated as safety issue: No ]
  

Prospective, multi-center, randomized study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant).

A minimum of 279 evaluable patients randomized 2:1 to MitraClip or mitral valve surgery, respectively, are required to test the primary safety and effectiveness endpoints of the RCT. Enrollment in the RCT is now complete. 60 roll-in patients were enrolled in the RCT. 78 patients were enrolled in the HRR, and 780 continued access patients may be enrolled.

38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US sites are participating in REALISM.

The RCT is powered to show and superiority of safety and non-inferiority of effectiveness of the MitraClip compared to mitral valve repair or replacement surgery. The HRR is powered to show lower mortality at 30 days with the MitraClip than predicted surgical mortality.