At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation per ASE guidelines
- ✓Symptomatic, or if asymptomatic must have new-onset atrial fibrillation, pulmonary hypertension, or left ventricular dysfunction
- ✓Candidate for mitral valve surgery
- ✕Requires other cardiac surgery or emergency surgery
- ✕Myocardial infarction within prior 12 weeks
- ✕Endovascular procedure within prior 30 days
- ✕Renal insufficiency
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)
In Brief
A clinical study evaluating Percutaneous mitral valve repair using MitraClip implant and Mitral valve repair or replacement surgery for Mitral Valve Insufficiency and 4 related conditions. Completed, enrolled 279 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
MitraClip Implant
Repair or replacement of mitral valve