Enable I Long-term Follow-up Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|