Brief Title
Enable® Aortic Sutureless Bioprosthesis Evaluation
Official Title
Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study
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.
Study Type
Observational
Primary Outcome
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.
Condition
Aortic Valve Stenosis
Intervention
Aortic Valve Replacement surgery
Study Arms / Comparison Groups
Aortic valve stenosis, aortic valve insufficiency
Description: Patients with aortic valve insufficiency and/or aortic valve stenosis who require AVR.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
225
Start Date
February 2013
Completion Date
April 2018
Primary Completion Date
April 2018
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Otto Dapunt, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01720342
Organization ID
EASE Enable
Responsible Party
Sponsor
Study Sponsor
Medtronic Bakken Research Center
Study Sponsor
Otto Dapunt, MD, Principal Investigator, LKH Universitätsklinik Graz, Austria
Verification Date
April 2019