Enable® Aortic Sutureless Bioprosthesis Evaluation

NCT01720342 | Completed

• 1 other identifier: EASE Enable
• Study Type: observational
• Target: 225
• Locations: 7 countries
• Sites: 17

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.

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Keywords

Medtronic Enable® aortic bioprosthesis; Aortic valve stenosis; Aortic valve insufficiency; "Real world" patients

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Aortic valve stenosis, aortic valve insufficiency

Patients with aortic valve insufficiency and/or aortic valve stenosis who require AVR.

Procedure: Aortic Valve Replacement surgery

Interventions

Aortic Valve Replacement surgery PROCEDURE

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

Also known as: Medtronic ATS 3f Enable® Aortic Bioprosthesis (Model 6000)

Aortic valve stenosis, aortic valve insufficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (17)

Centre Hospitalier Régional Universitaire de Lille (CHRU)

Lille, 59037, France

Location

Centre Hospitalier Universitaire de Saint-Etienne Hôpital Nord

Saint-Etienne, France

Location

Universitätsklinikum Düsseldorf (UKD)

Düsseldorf, 40225, Germany

Location

Medizinische Hochschule Hannover (MHH)

Hanover, 30625, Germany

Location

Deutssches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Universitätsklinikum Münster (UKM)

Münster, 48149, Germany

Location

Klinikum Oldenburg GmbH

Oldenburg, 26133, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Casa Di Cura Privata 'Montevergine' S.p.A.

Mercogliano, 83013, Italy

Location

Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Azienda Complesso Ospedaliero S.Filippo Neri

Rome, 00135, Italy

Location

Medisch Centrum Leeuwarden

Leeuwarden, 8934AD, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, 2300 RC, Netherlands

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospiten Rambla

Santa Cruz de Tenerife, 38001, Spain

Location

Inselspital

Bern, 3010, Switzerland

Location

The James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Related Publications (2)

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

  PMID: 21342776 BACKGROUND

• 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.

  PMID: 24787699 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Otto Dapunt, MD

  LKH Universitätsklinik Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: November 2, 2012
• Study Start: February 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

IT (3); FR (2); NL (2); CH (1); DE (6); ES (2); GB (1)