Aortic Valve Insufficiency, Aortic Valve Stenosis
Conditions
Keywords
Aortic Valve Replacement, Aortic Valve Bioprosthesis
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.
Interventions
DEVICEAortic Valve Replacement
Aortic Valve Replacement with Medtronic ATS 3f ENABLE® Aortic Bioprosthesis Model 6000
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany, Poland, Switzerland
Outcome results
None listed