Clinical Trial: Enable I Long-term Follow-up Study
Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational
Official Title: Enable I Long-term Follow-up Study
Brief Summary:
This was a prospective, non-randomized, multi-center, non-interventional post-market study. The study was a post-market long-term follow-up study based on the same cohort of patients (148 patients) enrolled in a previous investigational study from March 2007 to December 2009 (ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005) involving 10 European sites. Patient follow-up took place on a yearly basis up to 10 years after the implant/enrollment. Medtronic ATS Inc. retained the right to terminate this study at any time after the 5 year followup.
The primary objective of this study was to evaluate the safety and effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis during long-term follow-up.
As this was an observational study, safety and efficacy data were summarized and described. There was no statistically powered study hypothesis.
Detailed Summary:
Sponsor: Medtronic Bakken Research Center
Current Primary Outcome:
- Long-term safety of the Medtronic ATS Enable Aortic Bioprosthesis [ Time Frame: 10 Years Post-Procedure ]Following adverse events were addressed: Migration, Valve Related Thromboembolism, Valvular thrombosis, Haemorrhage, Perivalvular Leak, Endocarditis, Hmolysis, Structural valve Deterioration, Non-Structural Dysfunction, Reoperation, Explant and Death
- Long-term Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: NYHA Functional Classification [ Time Frame: 10 Years Post-Procedure ]
- Long-term Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: Hemodynamic Performance [ Time Frame: 10 Years Post-Procedure ]
Original Primary Outcome: Long-term safety and effectiveness [ Time Frame: 10 years after implant ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Medtronic Cardiovascular
Dates:
Date Received: July 6, 2012
Date Started: August 2012
Date Completion:
Last Updated: April 28, 2017
Last Verified: April 2017