Enable I Long-term Follow-up Study
|ClinicalTrials.gov Identifier: NCT01636648|
Recruitment Status : Terminated (Device was sunset from the market in May2015. No longer need for long term data.)
First Posted : July 10, 2012
Last Update Posted : November 21, 2017
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.
|Condition or disease||Intervention/treatment|
|Aortic Valve Stenosis Aortic Valve Insufficiency||Device: Aortic Valve Replacement|
|Study Type :||Observational|
|Actual Enrollment :||42 participants|
|Official Title:||Enable I Long-term Follow-up Study|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
- Device: Aortic Valve Replacement
Aortic Valve Replacement with Medtronic ATS 3f ENABLE® Aortic Bioprosthesis Model 6000
- Assess the Long-term safety of the Medtronic ATS Enable Aortic Bioprosthesis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 10 Years Post-Procedure ]Hemodynamic performance of the Aortic Bioprosthesis will be assessed by specific echocardiography measurements
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636648
|Johann Wolfgang Goethe University|
|Frankfurt, Germany, D-60590|
|University Medical Center Freiburg|
|Freiburg, Germany, 79106|
|University Medical Center Kiel|
|Kiel, Germany, 24105|
|Jagellonian University, John Paul the II Hospital|
|Kraków, Poland, 31-202|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Principal Investigator:||Thierry Carrel, Prof.||Inselspital Bern, Klinik für Herz-und Gefasschirurgie, CH-3010 Bern|