Pivotal Study of a Percutaneous Mitral Valve Repair System (EVERESTIIRCT)

Abbott

Status

Completed

Conditions

Mitral Valve Regurgitation

Mitral Valve Insufficiency

Mitral Insufficiency

Mitral Regurgitation

Mitral Valve Incompetence

Treatments

Procedure: Mitral valve repair or replacement surgery

Device: Percutaneous mitral valve repair using MitraClip implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00209274

Protocol #0401

Details and patient eligibility

About

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.

Full description

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.

Enrollment

279 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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