The purpose of this study is to determine whether an experimental device called the Trilogy Transcatheter Heart Valve (THV) System is as effective as surgical valve replacement (SAVR) in treating moderate-to-severe or severe aortic regurgitation (AR) requiring replacement of the native aortic valve. Aortic regurgitation is a condition in which the heart’s aortic valve does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of AR may include fatigue and shortness of breath. Participants will be randomly assigned to 1 of 2 groups. One group will be treated with the transcatheter aortic valve replacement (TAVR) procedure, which is a cardiovascular procedure that uses small cuts and flexible tube through blood vessels to reach the heart. The other group will undergo the surgical aortic valve replacement (SAVR) procedure using standard surgical valves, which is placed during an open-heart surgery to replace the aortic valve.
What is the full name of this clinical trial?
A Study to Assess Safety and Effectiveness of the JenaValve Trilogy? Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients with Aortic Regurgitation