Endovascular Valve Edge-to-Edge Repair Study II (EVEREST II).
Description of Research
The purpose of the study is to evaluate a new device and compare it to traditional heart surgery to replace or repair the mitral valve. The device is called the Cardiovascular Valve Repair System (CVRS). It consists of a delivery catheter (a flexible tube) and an implantable Clip to repair the mitral valve. The delivery catheter is inserted through a vein in the groin and guides the Clip into place so that it can be attached to the leaflets of the mitral valve. Once the Clip is in place on the mitral valve, the delivery catheter is removed.
Age 18 or older
Moderate to severe chronic mitral valve regurgitation
Candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass
Additional screening criteria