Enable® Aortic Sutureless Bioprosthesis Evaluation

Completed

• Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency
• Interventions: Procedure: Aortic Valve Replacement surgery

• Registration Number: NCT01720342
• Lead Sponsor: Medtronic Bakken Research Center

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.

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 Timeline

• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-02
• Study Start: 2013-02
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aortic valve stenosis, aortic valve insufficiency	Aortic Valve Replacement surgery	Patients with aortic valve insufficiency and/or aortic valve stenosis who require AVR.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (17)

Centre Hospitalier Régional Universitaire de Lille (CHRU); 🇫🇷 Lille, France

Deutssches Herzzentrum Muenchen; 🇩🇪 Munich, Germany

Centre Hospitalier Universitaire de Saint-Etienne Hôpital Nord; 🇫🇷 Saint-Etienne, France

Universitätsklinikum Düsseldorf (UKD); 🇩🇪 Duesseldorf, Germany

Universitätsklinikum Münster (UKM); 🇩🇪 Münster, Germany

Klinikum Oldenburg GmbH; 🇩🇪 Oldenburg, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Casa Di Cura Privata 'Montevergine' S.p.A.; 🇮🇹 Mercogliano, Italy

Azienda Complesso Ospedaliero S.Filippo Neri; 🇮🇹 Rome, Italy

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

Ospedale Luigi Sacco; 🇮🇹 Milan, Italy

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospiten Rambla; 🇪🇸 Santa Cruz de Tenerife, Spain

The James Cook University Hospital; 🇬🇧 Middlesbrough, United Kingdom

Inselspital; 🇨🇭 Bern, Switzerland

Leids Universitair Medisch Centrum; 🇳🇱 Leiden, Netherlands

Medizinische Hochschule Hannover (MHH); 🇩🇪 Hannover, Germany