Enable I Long-term Follow-up Study

Terminated

• Conditions: Aortic Valve Insufficiency; Aortic Valve Stenosis

• Registration Number: NCT01636648
• Lead Sponsor: Medtronic Bakken Research Center

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. 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 Description

Not available

Study Timeline

• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-10
• Study Start: 2012-08
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the Long-term safety of the Medtronic ATS Enable Aortic Bioprosthesis	10 Years Post-Procedure	Long-term safety will be assessed by collecting following reported adverse events addressed: Migration, Valve Related Thromboembolism, Valvular thrombosis, Haemorrhage, Perivalvular Leak, Endocarditis, Hmolysis, Structural valve Deterioration, Non-Structural Dysfunction, Reoperation, Explant and Death.
Assess the Long-term Clinical Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: NYHA Functional Classification	10 Years Post-Procedure	Long-term clinical effectiveness of the Aortic Bioprosthesis will be assessed by collecting the NYHA-class of enrolled subjects over a period of time, following surgery.
Long-term Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: Hemodynamic Performance	10 Years Post-Procedure	Hemodynamic performance of the Aortic Bioprosthesis will be assessed by specific echocardiography measurements

Trial Locations

Locations (6)

Jagellonian University, John Paul the II Hospital; 🇵🇱 Kraków, Poland

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Inselspital Bern; 🇨🇭 Bern, Switzerland

Johann Wolfgang Goethe University; 🇩🇪 Frankfurt, Germany

University Medical Center Freiburg; 🇩🇪 Freiburg, Germany

University Medical Center Kiel; 🇩🇪 Kiel, Germany