Enable® Aortic Sutureless Bioprosthesis Evaluation
This trial is active, not recruiting.
|Conditions||aortic valve stenosis, aortic valve insufficiency|
|Treatment||aortic valve replacement surgery|
|Sponsor||Medtronic Bakken Research Center|
|Start date||February 2013|
|End date||April 2020|
|Trial size||225 participants|
|Trial identifier||NCT01720342, EASE Enable|
The EASE Enable study is intended to collect additional data on the clinical outcomes of the Medtronic Enable® Aortic Bioprosthesis in "real world" patients.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Lille, France||Centre Hospitalier Régional Universitaire de Lille (CHRU)||no longer recruiting|
|Saint-Etienne, France||Centre Hospitalier Universitaire de Saint-Etienne Hôpital Nord||no longer recruiting|
|Duesseldorf, Germany||Universitätsklinikum Düsseldorf (UKD)||no longer recruiting|
|Hannover, Germany||Medizinische Hochschule Hannover (MHH)||no longer recruiting|
|Munich, Germany||Deutssches Herzzentrum Muenchen||no longer recruiting|
|Münster, Germany||Universitätsklinikum Münster (UKM)||no longer recruiting|
|Oldenburg, Germany||Klinikum Oldenburg GmbH||no longer recruiting|
|Ulm, Germany||Universitätsklinikum Ulm||no longer recruiting|
|Mercogliano, Italy||Casa Di Cura Privata 'Montevergine' S.p.A.||no longer recruiting|
|Milan, Italy||Ospedale Luigi Sacco||no longer recruiting|
|Rome, Italy||Azienda Complesso Ospedaliero S.Filippo Neri||no longer recruiting|
|Leeuwarden, Netherlands||Medisch Centrum Leeuwarden||no longer recruiting|
|Leiden, Netherlands||Leids Universitair Medisch Centrum||no longer recruiting|
|Madrid, Spain||Hospital General Universitario Gregorio Marañón||no longer recruiting|
|Santa Cruz de Tenerife, Spain||Hospiten Rambla||no longer recruiting|
|Bern, Switzerland||Inselspital||no longer recruiting|
|Middlesbrough, United Kingdom||The James Cook University Hospital||no longer recruiting|
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.
time frame: 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.
Male or female participants at least 18 years old.
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.
|Official title||Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study|
|Principal investigator||Otto Dapunt, MD|
|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.|
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