Overview

This trial is active, not recruiting.

Conditions mitral valve insufficiency, mitral valve regurgitation, mitral valve incompetence, mitral regurgitation, mitral insufficiency
Treatments percutaneous mitral valve repair using mitraclip implant, mitral valve repair or replacement surgery
Sponsor Evalve
Start date May 2005
End date November 2009
Trial size 1317 participants
Trial identifier NCT00209274, Protocol #0401

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Percutaneous mitral valve repair using MitraClip implant. The expected number of patients in the device arm is 186 (172 evaluable)
percutaneous mitral valve repair using mitraclip implant MitraClip
MitraClip Implant
(Active Comparator)
Mitral valve repair or replacement surgery.The expected number of patients in the active comparator arm is 93 (86 evaluable).
mitral valve repair or replacement surgery
Repair or replacement of mitral valve

Primary Outcomes

Measure
Freedom from surgery for valve dysfunction, death, and moderate to severe (3+) or severe (4+) mitral regurgitation (MR).
time frame: 12 months
Major adverse events (MAE)
time frame: 30 days

Secondary Outcomes

Measure
Major adverse events (MAE)
time frame: 12 months.
Major bleeding complications.
time frame: 30 days and 12 months.
Non-cerebral thromboembolism.
time frame: 30 days and 12 months.
Endocarditis.
time frame: 30 days and 12 months.
Thrombosis.
time frame: 30 days and 12 months.
Hemolysis.
time frame: 30 days and 12 months.
Clinically significant Atrial septal defect (ASD).
time frame: 30 days and 12 months.
Mitral Valve stenosis.
time frame: 30 days and 12 months.
New York Heart Association (NYHA) functional class cardiac disease.
time frame: 30 days, 6 months and 12 months
Acute procedural success
time frame: 30 Days
Post-procedure length of hospital stay.
time frame: 30 Days
Post-procedure intensive care unit (ICU) / critical care unit (CCU)/(post-anesthesia care unit) PACU duration.
time frame: 30 Days
Short Form (SF)-36 Quality of Life questionnaire.
time frame: 30 days and 12 months
MAE in patients over 75 years of age.
time frame: 12 months
Mitral valve repair success.
time frame: 12 months
Procedural success
time frame: 30 days
Freedom from surgery for valve dysfunction, death, and moderate to severe (3+) or severe (4+) mitral regurgitation.
time frame: 18 and 24 months
Clip implant rate
time frame: Day 0
Procedural freedom from MAE.
time frame: Day 0
Acute surgical success
time frame: 30 Days
Left Ventricular Status
time frame: 30 days and 12 months
Incidence of hospital readmissions for congestive heart failure (CHF).
time frame: 12 months pre- versus post-MitraClip
Number of days hospitalized for CHF.
time frame: 12 months pre- versus post-MitraClip
6 Minute Walk Test.
time frame: 30 days, 6 months, 12 months
Major vascular
time frame: 30 days and 12 months.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)
Principal investigator Ted Feldman, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Evalve.