Enable® Aortic Sutureless Bioprosthesis Evaluation (EASE)

April 29, 2019 updated by: Medtronic Bakken Research Center

Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study

The EASE Enable study is intended to collect additional data on the clinical outcomes of the Medtronic Enable® Aortic Bioprosthesis in "real world" patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Medtronic ATS 3f Enable® Aortic Bioprosthesis (Model 6000)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Bakken Research Center

Investigators

  • Principal Investigator: Otto Dapunt, MD, LKH Universitätsklinik Graz, Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 31, 2012

First Posted (Estimate)

November 2, 2012

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EASE Enable

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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