This study focuses on adults who have tricuspid regurgitation (TR), a condition in which the heart's tricuspid valve does not close tightly, causing blood to flow backwards in the wrong direction. The purpose of the study is to evaluate the safety and effectiveness of an investigational device called the EVOQUE system with Optimal Medical Therapy (OMT) compared to OMT alone in the treatment of patients with severe or greater tricuspid regurgitation. The EVOQUE Valve is an artificial valve made from bovine pericardial (cow heart) tissue, nitinol (metal) frame, and a fabric skirt. The valve is designed to replace the tricuspid heart valve without open-heart surgery and is implanted using a delivery catheter.
What is the full name of this clinical trial?
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device