The purpose of this study is to examine the safety and effectiveness of the investigational SAPIEN M3 System, a mitral valave replacement system, in patients with blood backflow (mitral regurgitation) across the mitral valve. The study focuses on individuals whose doctor have determined that they have moderate-severe to severe mitral regurgitation and are unsuitable for other commercial treatment options.
Since participants in this study are not candidates for open chest surgery, researchers believe that treatment with the study device could be a better way to improve their condition when compared to standard-of-care medical treatment. The standard medical treatments available to patients with mitral regurgitation who do not undergo surgery may temporarily reduce some symptoms but will not permanently improve their condition or cure mitral regurgitation.
What is the full name of this clinical trial?
The ENCIRCLE High-Risk Trial SAPIEN M3 System TransCatheter MItral Valve ReplaCement via TransseptaL AccEss