EASE: Enable® Aortic Sutureless Bioprosthesis Evaluation

Sponsor

Medtronic Bakken Research Center (Industry)

Overall Status

Completed

CT.gov ID

NCT01720342

Collaborator

(none)

225

Enrollment

Locations

61.9

Duration (Months)

13.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis Aortic Valve Insufficiency	Procedure: Aortic Valve Replacement surgery

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 Design

Study Type:

Observational

Actual Enrollment :

225 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

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. [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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