Enable® Aortic Sutureless bioprosthesis Evaluation (EASE study): A post-market release non-interventional study
- Conditions
- aortic valve disease10046973
- Registration Number
- NL-OMON39896
- Lead Sponsor
- Medtronic B.V.
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 65
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Hemodynamic performance of the Medtronic Enable aortic bioprosthesis at<br /><br>discharge, within 6 months following implantation, 1 year and annually<br /><br>thereafter up to 5 years post-implant.<br /><br>- New York Heart Association (NYHA) classification<br /><br>- Safety: includes all Serious Adverse Events (SAEs) and (Serious) Adverse<br /><br>Device Effects (ADEs/SADEs).<br /><br><br /><br>These variables will be evaluated by comparison with the baseline data and with<br /><br>published data in the literature.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>