First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System

Data will be collected at baseline, procedure, discharge (date of hospital discharge or 7 days post-implant, whichever occurs first), 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.

Inclusion criteria

• Written Informed Consent for participation prior to procedure.
• Legal age in host country.
• Aortic annulus 19-21mm diameter
• Senile degenerative aortic stenosis with derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of <1.0 cm2 (or aortic valve area index ≤ 0.6 cm2/m2)
• NYHA Functional Classification of II or greater.
• Predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
• Suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.

Exclusion criteria

• History of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of index procedure.
• Carotid artery disease requiring intervention.
• Myocardial infarction (MI) within 6 months (≤180 days) of the index procedure.
• Native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
• Mitral or tricuspid valvular regurgitation (grade II) or moderate to severe mitral stenosis.
• Aortic root angulation >70 degrees (horizontal aorta).
• Pre-existing prosthetic valve or prosthetic ring in any position. LVEF < 20%.
• Untreated coronary artery disease (CAD) requiring revascularization.
• Severe basal septal hypertrophy.
• Percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days or history of previous endocarditis.
• Uncontrolled atrial fibrillation (AF) or is in chronic AF without long term oral anticoagulation.
• Evidence of intracardiac mass, thrombus, or vegetation.
• Hemodynamic instability
• Significant pulmonary disease.
• Nonreactive pulmonary hypertension.
• Chronic steroid use.
• Hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
• Renal insufficiency as evidenced by a serum creatinine > 3.0 or end-stage renal disease requiring chronic dialysis.
• Morbid obesity defined as BMI ≥ 35.
• Subject's iliac arteries have severe calcification, tortuosity, diameter <6mm, or subject has had an aorto-femoral bypass.
• Ongoing infection or sepsis.
• Blood dyscrasias
• Significant aortic disease.
• Pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
• Active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 3 months (≤ 90 days) prior to the index procedure.