Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

Exclusion Criteria

• •Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated,
• •Any sepsis, including active endocarditis,
• •Recent myocardial infarction (\< 30 days),
• •Percutaneous coronary or vascular intervention within 15 days prior to the study procedure, or scheduled during or within 30 days after the study procedure,
• •Any left ventricular or atrial thrombus diagnosed by echocardiography,
• •Uncontrolled atrial fibrillation (heart rate greater than 100 bpm),
• •Mitral or tricuspid valvular insufficiency ( \> grade II),
• •Previous aortic valve replacement (mechanical valve OR stented bioprosthetic valve),
• •Any condition considered as contraindication for extracorporeal assistance,
• •Evolutive or recent CVA (cerebro vascular accident),
• •Poly arterial patients with either:
• •1. Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make insertion and endovascular access to the aortic valve impossible, or
• •2. Symptomatic carotid or vertebral arteries narrowing (\> 70%) disease, or
• •3. Abdominal or thoracic aortic aneurysm,
• •Bleeding diathesis or coagulopathy, or patient who will refuse blood transfusion,
• •Evolutive disease with life expectancy less than one year,
• •Creatinine clearance \< 20 ml/min,
• •Pregnancy, and
• •Enrolled in another investigational study.