NCT01720342

Enable® Aortic Sutureless Bioprosthesis Evaluation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 225 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Insufficiency

Interventions

Type	Name	Description
PROCEDURE	Aortic Valve Replacement surgery	Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis.

Timeline

• Start date: 2013-02-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2012-11-02
• Last updated: 2019-05-01

Locations

17 sites across 7 countries: France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom