Enable® Aortic Sutureless Bioprosthesis Evaluation

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

Detailed Description
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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.

Official Title
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Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study

Conditions
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Aortic Valve Stenosis, Aortic Valve Insufficiency

Intervention / Treatment
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* Procedure: Aortic Valve Replacement surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aortic valve stenosis, aortic valve insufficiency<br>Patients with aortic valve insufficiency and/or aortic valve stenosis who require AVR. | Procedure: Aortic Valve Replacement surgery<br>* Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis.<br>* Other names: Medtronic ATS 3f Enable® Aortic Bioprosthesis (Model 6000);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Clinical performance during implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 years post-procedure. | The early and late (up to five years) clinical performance of the Enable® aortic bioprosthesis will be characterized. Measures of clinical performance will include hemodynamic performance by echocardiography, New York Heart Association (NYHA) Functional Classification and safety (SAEs, ADEs, SADEs). | During implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 years post-procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medtronic Enable® aortic bioprosthesis, Aortic valve stenosis, Aortic valve insufficiency, Real world patients