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

Medtronic B.V.0 sites65 target enrollmentTBD

Overview

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

November 1, 2016

Last Updated

2 years ago

Study Type

Observational non invasive

Sponsor

•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.