Overview

This trial is active, not recruiting.

Conditions aortic valve stenosis, aortic valve insufficiency
Treatment aortic valve replacement surgery
Sponsor Medtronic Bakken Research Center
Start date February 2013
End date April 2020
Trial size 225 participants
Trial identifier NCT01720342, EASE Enable

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with aortic valve insufficiency and/or aortic valve stenosis who require AVR.
aortic valve replacement surgery Medtronic ATS 3f Enable® Aortic Bioprosthesis (Model 6000)
Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis.

Primary Outcomes

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.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study
Principal investigator Otto Dapunt, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.