Enable I Long-term Follow-up Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who were enrolled and implanted for the ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005
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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:
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ATS 3f Enable™ Aortic Bioprosthesis Model 6000 was explanted
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Patient died
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Patient lost to follow-up
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Patient withdrew consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johann Wolfgang Goethe University | Frankfurt | Germany | D-60590 | |
| 2 | University Medical Center Freiburg | Freiburg | Germany | 79106 | |
| 3 | University Medical Center Kiel | Kiel | Germany | 24105 | |
| 4 | Jagellonian University, John Paul the II Hospital | Kraków | Poland | 31-202 | |
| 5 | Universitätsspital Basel | Basel | Switzerland | CH-4031 | |
| 6 | Inselspital Bern | Bern | Switzerland | CH-3010 |
Sponsors and Collaborators
- Medtronic Bakken Research Center
Investigators
- Principal Investigator: Thierry Carrel, Prof., Inselspital Bern, Klinik für Herz-und Gefasschirurgie, CH-3010 Bern
Study Documents (Full-Text)
None provided.More Information
Publications
- Englberger L, Carrel TP, Doss M, Sadowski J, Bartus K, Eckstein FF, Asch FM, Martens S. Clinical performance of a sutureless aortic bioprosthesis: five-year results of the 3f Enable long-term follow-up study. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1681-7. doi: 10.1016/j.jtcvs.2014.03.054. Epub 2014 Apr 4.
- Martens S, Sadowski J, Eckstein FS, Bartus K, Kapelak B, Sievers HH, Schlensak C, Carrel T. Clinical experience with the ATS 3f Enable® Sutureless Bioprosthesis. Eur J Cardiothorac Surg. 2011 Sep;40(3):749-55. doi: 10.1016/j.ejcts.2010.12.068. Epub 2011 Feb 20.
- En_2012