Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access

Inclusion Criteria

• Subject has provided written informed consent prior to uploading CT scan to core lab.
• Subject is ≥ 18 years of age or legal age in host country.
• Subject's aortic annulus diameter meets the range indicated in the Instructions for Use as measured by multislice CT conducted within 180 days prior to the index procedure.
• Subject has senile degenerative aortic stenosis seen by echocardiography within 90 days of index procedure as measured by:
• mean gradient >40 mmHg
• Peak velocity ≥ 4.0 m/s
• Doppler Velocity Index 8% or documented heart team agreement ≥ high risk for SAVR due to frailty or co-morbidities

Exclusion Criteria

• Subject is unwilling or unable to comply with all study-required follow-up evaluations.
• Subject has a documented history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months (less than or equal to 180 days) prior to the index procedure.
• Subject has carotid artery disease requiring intervention.
• Subject has evidence of a myocardial infarction (MI) within 30 days prior to patient index procedure.
• Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
• Subject has severe mitral valvular regurgitation.
• Subject has severe mitral stenosis.
• Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position.
• Subject refuses any blood product transfusion.
• Subject has resting left ventricular ejection fraction (LVEF) less than 20%.
• Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
• Subject has had a percutaneous interventional or other invasive cardiovascular or peripheral vascular procedure less than or equal to 14 days prior to index procedure.
• Subject has severe basal septal hypertrophy that would interfere with transcatheter aortic valve placement.
• Subject has a history of, or is currently diagnosed with, endocarditis.
• There is imaging evidence of intracardiac mass, thrombus, or vegetation.
• Subject is considered hemodynamically unstable (requiring inotropic support or mechanical heart assistance).
• Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
• Subject with severe pulmonary disease as determined by STS score.
• Subject is on chronic oral steroid therapy.
• Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
• Subject has renal insufficiency as evidenced by a serum creatinine greater than 3.0 mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic dialysis.
• Subject has morbid obesity defined as a BMI greater than or equal to 40.
• Subject has ongoing infection or sepsis.
• Subject has uncontrolled blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg/dL), thrombocytopenia (platelet count <50,000 cells/mm3,).
• Anatomy falling outside the recommended values in the IFU, unless specifically approved by the Subject Selection Committee.
• Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure.
• Subject is currently participating in another investigational drug or device study, unless approved by the Sponsor.
• Subject has/had emergency surgery for any reason within 30 days of the index procedure.
• Subject has a life expectancy less than 1 year.
• Subject has other medical, social or psychological conditions that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude the subject from study participation.
• Subject is diagnosed with a state of dementia which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.
• Subject has a documented allergy to contrast media that cannot adequately be treated, nitinol a