Enable I Long-term Follow-up Study

Study Overview
=================
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.

Official Title
-----------------
Enable I Long-term Follow-up Study

Conditions
-----------------
Aortic Valve Stenosis, Aortic Valve Insufficiency

Intervention / Treatment
-----------------
* Device: Aortic Valve Replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Aortic Valve Replacement|Aortic Valve Replacement with Medtronic ATS 3f ENABLE® Aortic Bioprosthesis Model 6000|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Long-term safety of the Medtronic ATS Enable Aortic Bioprosthesis | 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. | 10 Years Post-Procedure | 
| Assess the Long-term Clinical Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: NYHA Functional Classification | 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. | 10 Years Post-Procedure | 
| Long-term Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: Hemodynamic Performance | Hemodynamic performance of the Aortic Bioprosthesis will be assessed by specific echocardiography measurements | 10 Years Post-Procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic Valve Replacement, Aortic Valve Bioprosthesis