The purpose of this study is to learn about the safety and performance of an experimental device called the J-Valve TF System. The device is designed to treat severe aortic regurgitation, (AR). AR occurs when the aortic valve does not close properly, which causes blood to leak back into the heart. People with severe symptomatic AR who are considered at high risk to open surgical aortic valve replacement will be suitable for the study. When compared to open chest surgery, the study procedure is less invasive, as it is performed through catheters in the Cath Lab. Patients enrolled and participating in the study will be followed by clinic visits up to 5 years.
What is the full name of this clinical trial?
J-Valve to Treat Aortic Regurgitation via Transcatheter Therapy