Heart Valve Disease
Conditions
Brief summary
The primary objective of this study is to compare two different regimens of therapy, AVK and ASA (aspirin), in the early postoperative period after aortic valve replacement with SJM Epic™ or SJM Epic™ Supra Porcine Bioprosthetic Heart Valve by establishing the adverse event free survival rate at 3 month post intervention follow-up of the 2 groups(with special focus on thromboembolic events and bleedings).
Interventions
DEVICEAortic valve replacement
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient requires, for the first time, isolated aortic valve replacement (pacemaker insertion is allowed) 2. Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements. 3. Patient is of legal age in the host country 4. The patient is in sinus rhythm before implantation
Exclusion criteria
1. Patient already has a prosthetic valve, other than the valve being replaced at this time. 2. Patient requires double valve implantation 3. Patient requires concomitant CABG 4. Patients requires intra aortic balloon pump at intervention 5. Patient has a medical condition which contraindicates implantation of the SJM Epic and/or SJM Epic Supra Porcine Bioprosthetic Heart Valve (e.g. patient on dialysis) 6. Patient requires ASA or AVK therapy, i.e. not suitable for randomization 7. Patient is pregnant or nursing. 8. Patient is affected by active endocarditis. 9. Patient is affected by aortic dissection. 10. Patient has history of cerebral ischemia 11. Patient is affected by coagulopathy, history of GI bleeding or increased bleeding risk 12. Patient is affected by peripheral vascular disease requiring treatment 13. Patient has previous chronic anticoagulation therapy 14. Patient is allergic to ASA and/or AVK
Outcome results
None listed