Enable® Aortic Sutureless bioprosthesis Evaluation (EASE study): A post-market release non-interventional study - EASE Enable

Medtronic B.V.0 个研究点目标入组 65 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

Trial is onging in other countries

•1. Patient with aortic valve stenosis, aortic valve insufficiency or a combination of the two.
•2. Patient requires replacement of his/her native aortic valve with a bioprosthesis with or
•without concomitant procedures.
•3. Patient is above the minimum age as required by local regulations to be participating in
•a clinical study.
•4. Patient is willing to return to the implant site for follow-up visits.
•5. Patient has been adequately informed of this clinical study and is willing to sign the
•patient Data Release Form.

•1. Patient requires replacement of two or more valves.
•2. Patient who underwent previous aortic valve replacement (AVR).
•3. Patient with native bicuspid aortic valve.
•4. Patient with active endocarditis or other systemic infection.
•5. Patient dilatation of the ascending aorta, deformations or irregular aortic annulus or
•ascending aorta geometry as seen via preoperative imaging.

发起方