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

October 22, 2012
November 23, 2013
February 2013
February 2020   (final data collection date for primary outcome 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. [ 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).
Same as current
Complete list of historical versions of study NCT01720342 on ClinicalTrials.gov Archive Site
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Enable® Aortic Sutureless Bioprosthesis Evaluation
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Aortic Valve Stenosis
  • Aortic Valve Insufficiency
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)
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.
Intervention: Procedure: Aortic Valve Replacement surgery
Martens S, Sadowski J, Eckstein FS, Bartus K, Kapelak B, Sievers HH, Schlensak C, Carrel T. Clinical experience with the ATS 3f Enable® Sutureless Bioprosthesis. Eur J Cardiothorac Surg. 2011 Sep;40(3):749-55. doi: 10.1016/j.ejcts.2010.12.068. Epub 2011 Feb 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
February 2020
February 2020   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Christian Vanoni +31 (0)43 3566566 christian.vanoni@medtronic.com
Germany,   Italy,   Netherlands,   Spain,   Switzerland
 
NCT01720342
EASE Enable
No
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Not Provided
Principal Investigator: Otto Dapunt, MD Klinikum Oldenburg, Germany
Medtronic Bakken Research Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP