The purpose of this study is to evaluate an investigational device called the Cephea Mitral Valve System, which is designed for the treatment of a diseased, damaged, or malfunctioning mitral valve. Specifically, the study aims to determine the safety and effectiveness of the Cephea Mitral Valve system for the treatment of a leaking mitral valve. Researchers want to test this device because it is a less invasive procedure than open heart surgical replacement of the mitral valve.

The study focuses on patients who have been diagnosed with mitral valve regurgitation, a condition in which the heart’s mitral valve does not close tightly, causing blood to flow backward in the heart. Stopping or decreasing mitral regurgitation helps blood flow more efficiently through the heart and the rest of the body. The Cephea Mitral Valve System includes the valve and an instrument set that allow study doctors to implant the valve. The valve is placed within the natural mitral valve.