Enable I Long-term Follow-up Study

Medtronic

Status: Terminated

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

Treatments: Device: Aortic Valve Replacement

Study type: Observational

Funder types: Industry

Identifiers

NCT01636648

En_2012

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who were enrolled and implanted for the ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005
• Patient willing to sign the new Data Release form (DRF) or Patient Informed Consent (PIC) for the post-market study (what is applicable for the study due to local requirements and regulations)

Exclusion criteria

• ATS 3f Enable™ Aortic Bioprosthesis Model 6000 was explanted
• Patient died
• Patient lost to follow-up
• Patient withdrew consent