Aortic Valve Stenosis
Conditions
Interventions
None listed
Sponsors
Edwards Lifesciences Services GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: the SAPIEN* valve is indicated for use in patients with symptomatic aortic stenosis (aortic valve area 20% or • STS Risk score >10
Exclusion criteria
Exclusion criteria: 1. Non-valvular aortic stenosis 2. Congenital aortic stenosis, unicuspid or bicuspid aortic valve 3. Non-calcific acquired aortic stenosis 4. Evidence of intracardiac mass, thrombus or vegetation 5. Untreated clinically significant coronary artery disease requiring revascularization 6. Severe deformation of the chest 7. Severe coagulation problems 8. Active bacterial endocarditis or other active infections 9. Myocardial infarction(MI) within one month 10. Unstable angina during index procedure 11. Recent pulmonary emboli 12. Recent(within 6 months) cerebrovascular accident (CVA) 13. Patients unable to tolerate anticoagulation therapy 14. Significant atheroma of femoral and iliac vessels 15. Severe tortuosities of the femoro-iliac vessels 16. Femoro-iliac vessels
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collect the safety and efficacy outcomes data of the commercially available Edwards SAPIEN* Valve intended for the treatment of severe calcific degenerative aortic stenosis at discharge or | — |
Secondary
| Measure | Time frame |
|---|---|
| Collect the safety and efficacy outcomes data of patients who received the commercially available Edwards SAPIEN* Valve for the treatment of severe calcific degenerative aortic stenosis at 1 year. | — |
Countries
Netherlands
Outcome results
None listed