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Enable® Aortic Sutureless Bioprosthesis Evaluation — EASE  

Aortic Valve Stenosis Clinical Trial

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

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01720342
Study type Observational
Source Medtronic Cardiovascular
Contact
Status Completed
Phase
Start date February 2013
Completion date April 2018
View Details
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