Enable® Aortic Sutureless Bioprosthesis Evaluation

Aortic Valve Stenosis Clinical Trial

— EASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720342
• Other study ID #: EASE Enable
• Status: Completed
• Start date: February 2013
• Est. completion date: April 2018

Study information

• Verified date: April 2019
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Stenosis

Intervention

Procedure:
• Aortic Valve Replacement surgery
Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis.

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Lille (CHRU)	Lille
France	Centre Hospitalier Universitaire de Saint-Etienne Hôpital Nord	Saint-Etienne
Germany	Universitätsklinikum Düsseldorf (UKD)	Duesseldorf
Germany	Medizinische Hochschule Hannover (MHH)	Hannover
Germany	Deutssches Herzzentrum Muenchen	Munich
Germany	Universitätsklinikum Münster (UKM)	Münster
Germany	Klinikum Oldenburg GmbH	Oldenburg
Germany	Universitätsklinikum Ulm	Ulm
Italy	Casa Di Cura Privata 'Montevergine' S.p.A.	Mercogliano
Italy	Ospedale Luigi Sacco	Milan
Italy	Azienda Complesso Ospedaliero S.Filippo Neri	Rome
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Leids Universitair Medisch Centrum	Leiden
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospiten Rambla	Santa Cruz de Tenerife
Switzerland	Inselspital	Bern
United Kingdom	The James Cook University Hospital	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.