Clinical Trial: Enable® Aortic Sutureless Bioprosthesis Evaluation
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study
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 Summary:
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.
Sponsor: Medtronic Bakken Research Center
Current Primary Outcome: 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. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Medtronic Cardiovascular
Dates:
Date Received: October 22, 2012
Date Started: February 2013
Date Completion: April 2020
Last Updated: April 17, 2017
Last Verified: April 2017
