Aortic Valve Insufficiency, Aortic Valve Stenosis
Conditions
Keywords
Medtronic Enable® aortic bioprosthesis, Aortic valve stenosis, Aortic valve insufficiency, Real world patients
Brief summary
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
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.
Interventions
PROCEDUREAortic Valve Replacement surgery
Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). |
Countries
France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Outcome results
None listed