ADVANCE Direct Aortic Study

Inclusion Criteria

• Severe symptomatic aortic valve stenosis requiring treatment
• Acceptable candidate for elective treatment with the Medtronic CoreValve® System according to the most recent version of the Medtronic CoreValve® Instructions For Use
• 21 years of age or older
• Patient is willing and able to comply with all protocol-specified follow-up evaluations
• The patient or legal representative 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")
• Patient will receive the CoreValve® device via direct aortic approach TAVI -

Exclusion Criteria

• Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
• Sepsis, including active endocarditis
• Recent myocardial infarction ( grade II)
• Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
• Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• Patients with:
• Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or
• Symptomatic carotid or vertebral arterial narrowing (>70%) disease, or
• Thoracic aortic aneurysm in the path of delivery system
• Bleeding diathesis or coagulopathy
• Patient refuses blood transfusion
• Estimated life expectancy of less than 12 months unless TAVI is performed
• Creatine clearance <20 mL/min
• Active gastritis or peptic ulcer disease
• Pregnancy or intent to become pregnant during study follow up
• Patient is participating in another trial that may influence the results of this study

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