Clinical trial NCT01720342: Enable® Aortic Sutureless Bioprosthesis Evaluation
Official title: Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Aortic Valve Insufficiency
Keywords: Medtronic Enable® aortic bioprosthesis
Aortic valve stenosis
Aortic valve insufficiency
"Real world" patients
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-11-02
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with aortic valve stenosis, aortic valve insufficiency or a combination of the two who require aortic valve replacement are eligible for this study, if they meet all study inclusion criteria and none of the exclusion criteria.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille (CHRU)
city: Saint-Etienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne Hôpital Nord
city: Duesseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf (UKD)
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
city: Munich
country: Germany
facility: Deutssches Herzzentrum Muenchen
city: Münster
country: Germany
facility: Universitätsklinikum Münster (UKM)
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg GmbH
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Mercogliano
country: Italy
facility: Casa Di Cura Privata 'Montevergine' S.p.A.
city: Milan
country: Italy
facility: Ospedale Luigi Sacco
city: Rome
country: Italy
facility: Azienda Complesso Ospedaliero S.Filippo Neri
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Santa Cruz de Tenerife
country: Spain
facility: Hospiten Rambla
city: Bern
country: Switzerland
facility: Inselspital
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
Study officials:
affiliation: LKH Universitätsklinik Graz, Austria
name: Otto Dapunt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.