A Study to Assess Safety and Probable Benefit of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of High Surgical Risk Patients with Symptomatic, Severe Aortic Regurgitation (AR)

11863ALIGN-AR-NCT04415047OpenA Study to Assess Safety and Probable Benefit of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of High Surgical Risk Patients with Symptomatic, Severe Aortic Regurgitation (AR)To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart 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. NCT04415047IndustrialAdultTreatmentDevice: JenaValve Pericardial TAVR SystemNonrheumatic aortic (valve) stenosisThis study investigates the following conditions or diseases: Aortic Regurgitation Aortic Valve Insufficiency Aortic Insufficiency Aortic Valve DiseaseWaksman, RonMedstar Washington Hospital CenterMCRN - Wash Interventional2026.1.0 Build 16 <a href="https://advarra.com" target="_blank">© 2026 Advarra, Inc.</a>