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Enable® Aortic Sutureless Bioprosthesis Evaluation (EASE)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center ) Identifier:
First received: October 22, 2012
Last updated: October 10, 2016
Last verified: October 2016
The EASE Enable study is intended to collect additional data on the clinical outcomes of the Medtronic Enable® Aortic Bioprosthesis in "real world" patients.

Condition Intervention
Aortic Valve Stenosis
Aortic Valve Insufficiency
Procedure: Aortic Valve Replacement surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study

Resource links provided by NLM:

Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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).

Enrollment: 225
Study Start Date: February 2013
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Aortic valve stenosis, aortic valve insufficiency
Patients with aortic valve insufficiency and/or aortic valve stenosis who require AVR.
Procedure: Aortic Valve Replacement surgery
Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis.
Other Name: Medtronic ATS 3f Enable® Aortic Bioprosthesis (Model 6000)

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01720342

Centre Hospitalier Régional Universitaire de Lille (CHRU)
Lille, France, 59037
Centre Hospitalier Universitaire de Saint-Etienne Hôpital Nord
Saint-Etienne, France
Universitätsklinikum Düsseldorf (UKD)
Duesseldorf, Germany, 40225
Medizinische Hochschule Hannover (MHH)
Hannover, Germany, 30625
Deutssches Herzzentrum Muenchen
Munich, Germany, 80636
Universitätsklinikum Münster (UKM)
Münster, Germany, 48149
Klinikum Oldenburg GmbH
Oldenburg, Germany, 26133
Universitätsklinikum Ulm
Ulm, Germany, 89081
Casa Di Cura Privata 'Montevergine' S.p.A.
Mercogliano, Italy, 83013
Ospedale Luigi Sacco
Milan, Italy, 20157
Azienda Complesso Ospedaliero S.Filippo Neri
Rome, Italy, 00135
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands, 8934AD
Leids Universitair Medisch Centrum
Leiden, Netherlands, 2300 RC
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospiten Rambla
Santa Cruz de Tenerife, Spain, 38001
Bern, Switzerland, 3010
United Kingdom
The James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Sponsors and Collaborators
Medtronic Bakken Research Center
Principal Investigator: Otto Dapunt, MD LKH Universitätsklinik Graz, Austria
  More Information

Responsible Party: Medtronic Bakken Research Center Identifier: NCT01720342     History of Changes
Other Study ID Numbers: EASE Enable 
Study First Received: October 22, 2012
Last Updated: October 10, 2016
Health Authority: Germany: Ethics Commission
Switzerland: Ethikkommission
France: Conseil National de l'Ordre des Médecins
Italy: Ethics Committee
Italy: Ministry of Health
Netherlands: Medical Ethics Review Committee (METC)
Austria: Ethikkommission
Spain: Ethics Committee
United Kingdom: Research Ethics Committee
United Kingdom: National Institute for Health Research

Keywords provided by Medtronic Cardiovascular:
Medtronic Enable® aortic bioprosthesis
Aortic valve stenosis
Aortic valve insufficiency
"Real world" patients

Additional relevant MeSH terms:
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction processed this record on January 17, 2017