Enable® Aortic Sutureless Bioprosthesis Evaluation (EASE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Medtronic Bakken Research Center
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01720342
First received: October 22, 2012
Last updated: November 23, 2013
Last verified: November 2013
  Purpose

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 Bakken Research Center:

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).


Estimated Enrollment: 800
Study Start Date: February 2013
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
aortic valve stenosis, aortic valve insufficiency
Patients with aortic valve stenosis, aortic valve insufficiency or a combination of the two who require aortic valve replacement and who are selected to be treated with the Enable® aortic bioprosthesis.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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 ClinicalTrials.gov identifier: NCT01720342

Contacts
Contact: Christian Vanoni +31 (0)43 3566566 christian.vanoni@medtronic.com

Locations
Germany
Universitätsklinikum Düsseldorf (UKD) Recruiting
Duesseldorf, Germany, 40225
Contact: Payam Akhyari    +49 (0) 211 - 8 11 79 25    payam.akhyari@med.uni-duesseldorf.de   
Principal Investigator: Artur Lichtenberg, Prof. Dr.         
Medizinische Hochschule Hannover (MHH) Recruiting
Hannover, Germany, 30625
Contact: Stefanie Zimmermann    0511 532-5061    Zimmermann.Stefanie@mh-hannover.de   
Principal Investigator: Malakh Lal Shrestha, Prof. Dr. med.         
Universitätsklinikum Münster (UKM) Active, not recruiting
Münster, Germany, 48149
Klinikum Oldenburg GmbH Recruiting
Oldenburg, Germany
Contact: Pia Modersitzki-Osan    0049 441 403 2820    Modersitzki-Osan.Pia@klinikum-oldenburg.de   
Principal Investigator: Otto Dapunt, Prof.         
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89081
Contact: Patrizia Acri    0731-500 54303    Patrizia.Acri@uniklinik-ulm.de   
Principal Investigator: Andreas Liebold, Prof. Dr.         
Italy
Ospedale Luigi Sacco Recruiting
Milan, Italy, 20157
Contact: Silvia Carrettoni    02 3904.2333    carrettoni.silvia@hsacco.it   
Principal Investigator: Carlo Antona, Prof. Dr. med.         
Netherlands
Medisch Centrum Leeuwarden Recruiting
Leeuwarden, Netherlands, 8934AD
Contact: Jan Germ van der Tempel    +31 55 2863732    j.van.der.tempel@ZNB.nl   
Principal Investigator: Hafid Amrane, Dr.         
Leids Universitair Medisch Centrum Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Eline Bruggemans, MSc    +31 71 526 4581    e.f.bruggemans@lumc.nl   
Principal Investigator: Robert Klautz, Prof.         
Spain
Hospital General Universitario Gregorio Marañón Not yet recruiting
Madrid, Spain, 28007
Contact: Lourdes Viedma       lviedma.hgugm@salud.madrid   
Principal Investigator: Angel G. Pinto, Dr.         
Hospiten Rambla Recruiting
Santa Cruz de Tenerife, Spain, 38001
Contact: Eduard Permanyer, Dr.    +34 620 75 77 21    eduard.permanyer@hospiten.com   
Principal Investigator: Rafael Llorens, Dr.         
Switzerland
Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Lars Englberger, PD Dr. med.    +41 (0)31 632 15 71    lars.englberger@insel.ch   
Contact: Dorothee Keller    +41 31 632 3606    Dorothee.Keller@insel.ch   
Principal Investigator: Lars Englberger         
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Otto Dapunt, MD Klinikum Oldenburg, Germany
  More Information

Publications:
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01720342     History of Changes
Other Study ID Numbers: EASE Enable
Study First Received: October 22, 2012
Last Updated: November 23, 2013
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)

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

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 26, 2014