Pivotal Study of a Percutaneous Mitral Valve Repair System
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/9/2018 |
| Start Date: | August 2005 |
| End Date: | December 2014 |
Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)
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 of REALISM is closed. Enrollment in the high
risk arm of REALISM 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.
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 of REALISM is closed. Enrollment in the high
risk arm of REALISM 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 under EVEREST II
RCT.
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 test the hypothesis MitraClip has both superiority of safety and
non-inferiority of effectiveness 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.
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 under EVEREST II
RCT.
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 test the hypothesis MitraClip has both superiority of safety and
non-inferiority of effectiveness 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.
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:
- 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 for MitraClip
- 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
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