Pivotal Study of a Percutaneous Mitral Valve Repair System

NCT ID: NCT00209274

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2014-12-31

Brief Summary

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.

Detailed 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.

Conditions

Mitral Valve Insufficiency; Mitral Valve Regurgitation; Mitral Valve Incompetence; Mitral Regurgitation; Mitral Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Percutaneous mitral valve repair using MitraClip implant. The calculated sample size was 186 patients in the device arm

Group Type: EXPERIMENTAL

Percutaneous mitral valve repair using MitraClip implant

Intervention Type: DEVICE

MitraClip Implant

2

Mitral valve repair or replacement surgery. The calculated sample size was 93 patients in the control arm.

Group Type: ACTIVE_COMPARATOR

Mitral valve repair or replacement surgery

Intervention Type: PROCEDURE

Repair or replacement of mitral valve

Interventions

Percutaneous mitral valve repair using MitraClip implant

MitraClip Implant

Intervention Type: DEVICE

Mitral valve repair or replacement surgery

Repair or replacement of mitral valve

Intervention Type: PROCEDURE

Other Intervention Names

MitraClip

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ted Feldman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Donald G Glower Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center, Department of Surgery

Locations

Evanston Northwestern Healthcare

Evanston, Illinois, United States

Countries

United States

References

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Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, Smalling RW, Siegel R, Rose GA, Engeron E, Loghin C, Trento A, Skipper ER, Fudge T, Letsou GV, Massaro JM, Mauri L; EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011 Apr 14;364(15):1395-406. doi: 10.1056/NEJMoa1009355. Epub 2011 Apr 4.

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Other Identifiers

Protocol #0401

Identifier Type: -

Identifier Source: secondary_id

Protocol #0401

Identifier Type: -

Identifier Source: org_study_id