To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR
Patient with NYHA functional class III/IV
Patient with high risk for SAVR as documented by Heart Team.
Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System
Patient or the patient's legal representative has provided written informed consent
Congenital uni- or bicuspid (Sievers 0) aortic valve morphology
Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
Mitral regurgitation > moderate
Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure
Single group
JenaValve Trilogy Heart Valve System
DeviceTAVR with JenaValve Trilogy Heart Valve System
Device Success
Freedom from unsuccessful delivery of the device, and retrieval of the delivery system
Device Positioning
Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location
Device Performance
Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)\*
Surgery/intervention related to device
Freedom from surgery or intervention related to the device# or to a major vascular or access-related or cardiac structural complication
Device Success
Freedom from unsuccessful delivery of the device, and retrieval of the delivery system
Device Positioning
Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location
Device Performance
Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)\*
Surgery/intervention related to device
Freedom from surgery or intervention related to the device# or to a major vascular or access-related or cardiac structural complication
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