October 1, 2008
Evalve Completes Enrollment for Mitral Regurgitation Study
Evalve has completed randomized enrollment in the endovascular valve edge-to-edge repair study, which is evaluating the MitraClip system as a non-surgical repair option for patients suffering from mitral regurgitation.
Endovascular valve edge-to-edge repair (Everest) study is an FDA-approved Phase II randomized, controlled, multi-center clinical research study in the US and Canada evaluating the safety and efficacy of the MitraClip device in 279 patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation (MR), as compared to surgical repair or replacement.
The study effectiveness endpoint requires an MR reduction to less than or equal to 2+ at one year. The primary effectiveness endpoint is freedom from surgery for valve dysfunction, death, and moderate-to-severe or severe MR at 12 months. The primary safety endpoint is freedom from major adverse events at 30 days or hospital discharge whichever is longer.
Overall, Everest investigators have treated more than 350 patients with over 450 MitraClip devices implanted. Clinical data continues to grow and a significant number of three-year follow-up results are available as well as four-year data from a smaller group of patients, said Evalve.
Donald Glower, professor of surgery at Duke Medical Center and co-principal investigator of the Everest study, said: "This trial sets a high scientific standard for future percutaneous valve therapies. As a result, this trial will have a significant and long-lasting impact on patient care around the world."