The purpose of this study is to evaluate the safety and effectiveness of an experimental device called the AltaValve System in people with moderate-to-severe and severe mitral regurgitation. The study aims to determine whether the device can help treat a leaky valve; it involves a procedure that is less invasive than open heart replacement of the mitral valve. Study procedures include transcatheter mitral valve replacement procedure and clinic visits. A smaller study to assess the safety of the AltaValve System was already completed; this study is being conducted to confirm AltaValve System’s long-term effectiveness. The AltaValve is a self-expandable device created to fit the patient’s heart. The tissue valve is a man-made valve that imitates the patient’s own mitral valve leaflets (leaf-like structures that help control the blood flow in the heart). The fabric and tissue are intended to reduce or stop the leakage of the mitral valve.
What is the full name of this clinical trial?
AltaValve Pivotal Trial Protocol