Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
225 participants
OBSERVATIONAL
2013-02-28
2018-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Aortic valve stenosis, aortic valve insufficiency
Patients with aortic valve insufficiency and/or aortic valve stenosis who require AVR.
Aortic Valve Replacement surgery
Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis.
Interventions
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Aortic Valve Replacement surgery
Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Otto Dapunt, MD
Role: PRINCIPAL_INVESTIGATOR
LKH Universitätsklinik Graz, Austria
Locations
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Centre Hospitalier Régional Universitaire de Lille (CHRU)
Lille, , France
Centre Hospitalier Universitaire de Saint-Etienne Hôpital Nord
Saint-Etienne, , France
Universitätsklinikum Düsseldorf (UKD)
Düsseldorf, , Germany
Medizinische Hochschule Hannover (MHH)
Hanover, , Germany
Deutssches Herzzentrum Muenchen
Munich, , Germany
Universitätsklinikum Münster (UKM)
Münster, , Germany
Klinikum Oldenburg GmbH
Oldenburg, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Casa Di Cura Privata 'Montevergine' S.p.A.
Mercogliano, , Italy
Ospedale Luigi Sacco
Milan, , Italy
Azienda Complesso Ospedaliero S.Filippo Neri
Rome, , Italy
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospiten Rambla
Santa Cruz de Tenerife, , Spain
Inselspital
Bern, , Switzerland
The James Cook University Hospital
Middlesbrough, , United Kingdom
Countries
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References
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Martens S, Sadowski J, Eckstein FS, Bartus K, Kapelak B, Sievers HH, Schlensak C, Carrel T. Clinical experience with the ATS 3f Enable(R) Sutureless Bioprosthesis. Eur J Cardiothorac Surg. 2011 Sep;40(3):749-55. doi: 10.1016/j.ejcts.2010.12.068. Epub 2011 Feb 20.
Englberger L, Carrel TP, Doss M, Sadowski J, Bartus K, Eckstein FF, Asch FM, Martens S. Clinical performance of a sutureless aortic bioprosthesis: five-year results of the 3f Enable long-term follow-up study. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1681-7. doi: 10.1016/j.jtcvs.2014.03.054. Epub 2014 Apr 4.
Other Identifiers
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EASE Enable
Identifier Type: -
Identifier Source: org_study_id
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