Enable® Aortic Sutureless Bioprosthesis Evaluation
Enable® Aortic Sutureless Bioprosthesis Evaluation
The EASE Enable study is intended to collect additional data on the clinical outcomes of the
 Medtronic Enable® Aortic Bioprosthesis in "real world" patients.
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.
Inclusion Criteria:

 -  Patient with aortic valve stenosis, aortic valve insufficiency or a combination of the
 two.

 -  Patient requires replacement of his/her native aortic valve with a bioprosthesis with
 or without concomitant procedures.

 -  Patient is above the minimum age as required by local regulations to be participating
 in a clinical study.

 -  Patient is willing to return to the implant site for follow-up visits.

 -  Patient has been adequately informed of this clinical study and is willing to sign the
 patient Data Release Form.

 Exclusion Criteria:

 -  Patient requires replacement of two or more valves.

 -  Patient who underwent previous aortic valve replacement (AVR).

 -  Patient with native bicuspid aortic valve.

 -  Patient with active endocarditis or other systemic infection.

 -  Patient dilatation of the ascending aorta, deformations or irregular aortic annulus or
 ascending aorta geometry as seen via preoperative imaging.