Enable® Aortic Sutureless Bioprosthesis Evaluation (EASE)

Medtronic

Status: Completed

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

Treatments: Procedure: Aortic Valve Replacement surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT01720342

EASE Enable

Details and patient eligibility

About

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

Full description

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.

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

225 participants in 1 patient group

Aortic valve stenosis, aortic valve insufficiency

Description:

Patients with aortic valve insufficiency and/or aortic valve stenosis who require AVR.

Treatment:

Procedure: Aortic Valve Replacement surgery