The EASE Enable study is intended to characterize the clinical performance of the Medtronic Enable® aortic bioprosthesis in a post-market real-world setting.~This is a Non-randomized, prospective, non-interventional multi-center post-market release (PMR) study. Up to 800 subjects will be enrolled at up to 40 centers in Europe. After aortic valve replacement with the Enable® aortic bioprosthesis, each patient will have routine follow-up visits at the following intervals: at 30 days post-implant (at 30 days post-implant or prior to hospital discharge, whatever comes first), within 6 months following implantation, 1 year and annually thereafter up to 5 years post-implant.
The EASE Enable study is intended to collect additional data on the clinical outcomes of the Medtronic Enable® Aortic Bioprosthesis in real world patients.