aortic stenosis
Conditions
Interventions
The Medtronic CoreValve® System consists of the following elements:
• Percutaneous Aortic Valve Bioprosthesis (PAV): consisting of a multi-level
self expanding frame with porcine pericardial bioprost
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Severe symptomatic aortic valve stenosis requiring treatment 2. Acceptable candidate for elective treatment with the Medtronic CoreValve® System (according to the most recent version of the Medtronic CoreValve® Instructions For Use) and in conformity with the local regulatory and medico economic context 3. 21 years of age or older 4. Patient is willing and able to comply with all protocol-specified follow-up evaluations 5. The patient has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form (*Patient Informed Consent Form*) 6. Patient will receive the CoreValve® device via direct aortic approach TAVI
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated 2. Sepsis, including active endocarditis 3. Recent myocardial infarction (grade II) 7. Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve) 8. Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA) 9. Patients with: a. Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or b. Symptomatic carotid or vertebral arterial narrowing (>70%) disease, or c. Thoracic aortic aneurysm in the path of delivery system 10. Bleeding diathesis or coagulopathy 11. Patient refuses blood transfusion 12. Estimated life expectancy of less than 12 months unless TAVI is performed 13. Creatine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is defined as all-cause mortality at 30 days post-implant. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints are defined: 1. All-cause mortality at discharge, 6 months and 12 months. 2. Cardiovascular mortality at discharge, 30 days, 6 months and 12 months. 3. Incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)-events at discharge, 30 days, 6 months and 12 months. MACCE is defined as a composite of: • All-cause mortality • Myocardial Infarction (MI) • All stroke • Reintervention (defined as any cardiac surgery or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve (after closure of the thorax of the previous implanted valve) 4. Incidence of individual MACCE components at discharge, 30 days, 6 months and 12 months 5. Incidence of non-disabling and disabling stroke (and ischemic vs hemorrhagic stroke) at discharge, 30 days, 6 months and 12 months 6. Device success at discharge Device success defined as follows: • Absence of procedural mortality AND • Correct positioning of a single prosthetic heart valve into the proper anatomical location AND intended performance of the prosthetic heart valve (no prosthesis-patient mismatch) and mean aortic valve gradient 30 days after the index procedure) for valve-related issues or cardiac decompensation. 13. Change in NYHA class from baseline at 30 days, 6 months and 12 months. 14. Length of implant procedure. 15. Length of implant hospital stay. 16. Length of fluoroscopy time during implant. 17. Incidence of Acute Kidney Injury at baseline and discharge. 18. Patient health status evaluated by Quality of Life Questionnaires (EQ-5D and SF-12v2) at baseline, 30 days, 3 months (EQ-5D only), 6 months and 12 months. 19. Patient health status evaluated by Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 30 days, 6 months and 12 months. 20. Prosthetic valve performance evaluated by: 1) Echocardiographic assessment at discharge, 6 months and12 months using the fo | — |
Countries
Netherlands
Outcome results
None listed