Restore-MV: Coapsy System for Support of Mitral Valve

Study of:
The purpose of this study is to evaluate the effectiveness of of coapsy for patients with mitral valve regurgitation.

Mitral valve regurgitation (MR) is a condition in which the mitral valve (located between the atrium and ventricle on the left side of the heart) leaks. This leakage is due to dilation of the mitral valve and separation of the mitral valve leaflets. Patients with mild MR are generally non-symptomatic; however, as the disease progresses, they may experience dyspnea and fatigue due to low cardiac output and elevated filling pressures. In severe cases, MR may trigger atrial fibrillation and increase the risk of stroke. Severe MR can also adversely affect the function and compliance of the left ventricle, eventually leading to heart failure. Functional MR is a frequent outcome of ischemic heart disease or dilated cardiomyopathy.

The Coapsys is a permanently implantable device intended to repair mitral valve regurgitation. The Coapsys is designed to provide a surgical option for mitral valve repair that does not require the use of cardiac arrest (stopping of the heart) or an atriotomy (opening of the heart at the atrium). The implant procedure involves the placement of two pads on the outside of the heart. These pads are connected by a flexible string, which passes around the heart. The pads are pulled together, decreasing the distance between them.

Thomas F. Flavin, MD

Dave Chose, RN

For more information about this study or the Cardiovascular Surgery Research program at the Minneapolis Heart Institute Foundation, please email Dave Chose, RN at 612-863-3834.