Overview

This trial is active, not recruiting.

Conditions aortic valve stenosis, aortic valve insufficiency
Treatment aortic valve replacement
Sponsor Medtronic Bakken Research Center
Start date August 2012
End date April 2020
Trial size 42 participants
Trial identifier NCT01636648, En_2012

Summary

This is a prospective, non-randomized, multi-center, non-interventional post-market study. The study is 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 will take place on a yearly basis up to 10 years after the implant/enrollment. Medtronic ATS Inc. retains the right to terminate this study at any time after the 5 year followup.

The primary objective of this study is to evaluate the safety and effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis during long-term follow-up.

As this is an observational study, safety and efficacy data will be summarized and described. There is no statistically powered study hypothesis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Long-term safety and effectiveness
time frame: 10 years after implant

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Enable I Long-term Follow-up Study
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.