Text Size

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

This study is currently recruiting participants.
Verified October 2012 by Evalve
Sponsor:
Information provided by:
Evalve
ClinicalTrials.gov Identifier:
NCT00209274
First received: September 13, 2005
Last updated: October 24, 2012
Last verified: October 2012
History of Changes

September 13, 2005
October 24, 2012
May 2005
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • The primary effectiveness endpoint is freedom from surgery for valve dysfunction, death, and moderate to severe (3+) or severe (4+) mitral regurgitation at 12 months.
  • The primary safety endpoint is freedom from major adverse events (MAE) at 30 days.
Complete list of historical versions of study NCT00209274 on ClinicalTrials.gov Archive Site
  • 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 ]
  • -Major vascular and bleeding complications
  • -Non-cerebral thromboembolism
  • -Endocarditis
  • -Thrombosis
  • -Hemolysis
  • -Atrial septal defect
  • -MV stenosis
  • -NYHA classification
  • -Acute Procedural Success
  • -Post-procedure length of hospital stay
  • -Quality of Life
Not Provided
Not Provided
 
Pivotal Study of a Percutaneous Mitral Valve Repair System (EVEREST II)
Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVEREST II) and Real World ExpAnded MuLtIcenter Study of the MitraClip System (REALISM).

EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm is closed. Enrollment in the high risk arm is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Mitral Valve Insufficiency
  • Mitral Valve Regurgitation
  • Mitral Valve Incompetence
  • Mitral Regurgitation
  • Mitral Insufficiency
  • Device: Percutaneous mitral valve repair using MitraClip implant
    MitraClip Implant
    Other Name: MitraClip
  • Procedure: Mitral valve repair or replacement surgery
    Repair or replacement of mitral valve
  • Experimental: 1
    Percutaneous mitral valve repair using MitraClip implant.
    Intervention: Device: Percutaneous mitral valve repair using MitraClip implant
  • Active Comparator: 2
    Mitral valve repair or replacement surgery.
    Intervention: Procedure: Mitral valve repair or replacement surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
957
December 2017
December 2013   (final data collection date for primary outcome measure)

Key Inclusion/Exclusion Criteria:

Patients with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR) based on American Society of Echocardiography guidelines:

RCT and REALISM non-high risk arm:

  • Are 18 years or older.
  • Symptomatic
  • If asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction
  • Are candidates for mitral valve surgery
  • Are candidates for transseptal catheterization
  • Primary regurgitant jet must originate from malcoaptation of the A2 and P2 scallops of the mitral valve
  • Appropriate valve anatomy
  • Does not need other cardiac surgery or any emergency surgery
  • Did not experience myocardial infarction in prior 12 weeks or endovascular procedure in prior 30 days
  • Mitral valve orifice area ≥ 4 cm2
  • Do not have renal insufficiency
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation

HRR and REALISM high risk arm:

  • Are 18 years or older.
  • Symptomatic
  • Are high risk for mitral valve surgery defined by Society of Thoracic Surgery (STS) mortality risk ≥ 12% or due to surgical risk factors not included in the STS
  • Are candidates for transseptal catheterization
  • Primary regurgitant jet must originate from malcoaptation of the A2 and P2 scallops of the mitral valve
  • Appropriate valve anatomy
  • Did not experience myocardial infarction in prior 2 weeks
  • Mitral valve orifice area ≥ 4 cm2
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Both
18 Years and older
No
Contact: Jill A Hannemann 650-833-1654 jill.hannemann@av.abbott.com
Contact: Chrysbe D Madayag 650-833-1650 chrysbe.madayag@av.abbott.com
United States
 
NCT00209274
Protocol #0401, Protocol #0401
Yes
Elizabeth McDermott, Divisional Vice President of Regulatory and Clinical Affairs, Abbott Vascular Structural Heart (Evalve Inc)
Evalve
Not Provided
Principal Investigator: Ted Feldman, M.D. NorthShore University HealthSystem Research Institute
Principal Investigator: Donald G Glower Jr., MD Duke University Medical Center, Department of Surgery
Evalve
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP