The purpose of this study is to determine the safety and effectiveness of an investigational device called the Innovalve TMVR system for the treatment of a leaking mitral valve (mitral valve regurgitation). Mitral valve regurgitation happens when the heart’s mitral valve does not close tightly, allowing 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. Researchers want to test this device because it is a less invasive procedure than open heart surgical replacement of the mitral valve. Innovalve’s Transseptal Mitral Valve Replacement System is an implantable bioprosthetic (artificial) mitral valve replacement device, meaning that once implanted, it will be in the same location as the patient’s native mitral valve and will function in its place.
What is the full name of this clinical trial?
Prospective, single-arm, early feasibility study for the treatment of subjects with moderate-severe or severe symptomatic mitral valve regurgitation using the Innovalve Transseptal Mitral Valve Replacement System