NCT01636648

Enable I Long-term Follow-up Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	Aortic Valve Replacement	Aortic Valve Replacement with Medtronic ATS 3f ENABLE® Aortic Bioprosthesis Model 6000

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2012-07-10
• Last updated: 2017-11-21

Locations

6 sites across 3 countries: Germany, Poland, Switzerland