EVEREST II

EVEREST II is an ongoing Phase II FDA approved clinical research study to assess the safety and efficacy (or effectiveness) of the MitraClip system for patients diagnosed with Grade 3 (moderate to severe) or Grade 4 (severe) MR. Study participants will be required to have a number of follow-up visits and evaluations including ultrasound studies over the course of at least a 24-month period following treatment. These follow up visits are intended to monitor the outcome of the procedure. EVEREST II consists of a randomized arm and a high risk registry arm.

EVEREST II Randomized Arm

This study arm compares the MitraClip procedure to the current standard of care, mitral valve surgery. To ensure that the results are unbiased, participants will be randomly assigned to either the MitraClip procedure or to surgery, in a "two-to-one" ratio. This means that two out of 3 of trial participants will undergo the MitraClip procedure and one out of 3 of trial participants will undergo mitral valve surgery. Initiated in late 2005, this arm will enroll approximately 300 patients.

EVEREST II High Risk Registry Arm

Enrollment in the High Risk Registry arm was successfully completed in January of 2008. This study arm was designed to evaluate the safety and efficacy of the MitraClip device in patients who are considered to be at high risk of not surviving surgery.

To find out whether you may qualify for the randomized arm of EVEREST II, please call toll-free: 1-877-MY-MR-FIX / (877) 696-7349. Click here to link to the EVEREST II Call Center. All information provided to the call center is kept confidential and used only for the purposes of determining eligibility to participate in this study. Alternatively, you can contact an investigational site in your area. Click here to view an interactive map of the investigational sites.

Key inclusion criteria include moderate to severe or severe MR with symptoms or, if asymptomatic, evidence of left ventricular dysfunction; regurgitation originating from the A2-P2 scallops of the mitral valve; and qualification for mitral valve surgery including cardiopulmonary bypass.

Key exclusion criteria include endocarditis, rheumatic heart disease, and renal insufficiency. There is no upper age limit. Eligibility can be determined through a review of the patient's medical history in conjunction with a review of the patient's echocardiogram.