Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Safety and Efficacy of the Transapical and Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Regurgitation (AR)
Brief Summary: The purpose of this research study is to collect information about a new treatment for severe aortic regurgitation, which affects the aortic valve in the heart. Aortic regurgitation is a condition where the heart's aortic valve does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery. A less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat severe aortic regurgitation. The JenaValve replacement valve is placed inside the aortic valve by using the JenaValve delivery system. The JenaValve replacement valve may be implanted in one of two ways: (1) transapical - where the valve is implanted through the chest wall, and (2) transfemoral - where the valve is implanted through an artery in the groin. The choice of which implant method will be used is decided by the doctor.