Portico TAVI Implant With Transfemoral Delivery System

Data will be collected at baseline, procedure, discharge, 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.

Inclusion criteria

• Subject has given written study Informed Consent for participation prior to procedure.
• 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 echocardiogram (echo) or CT conducted within the past 90 days.
• Subject has senile degenerative aortic stenosis with echocardiography (echo) 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). (Baseline measurement taken by echo within 30 days of procedure).
• Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater.
• Subject is deemed high operable risk and suitable for TAVI per the medical opinion of the Subject Selection Committee (See Section 3.1 for the definition of the Subject Selection Committee)
• Subject's predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
• In the opinion of the Subject Selection Committee and based upon angiographic measurements, the subject has suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.
• Subject has structurally normal cardiac anatomy.
• Subject is willing and able to comply with all required follow-up evaluations.

Exclusion criteria

• Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of the index procedure.
• Subject has carotid artery disease requiring intervention.
• Subject has evidence of a myocardial infarction (MI) within the past 6 months (≤180 days) of the index procedure.
• Subject has hypertrophic cardiomyopathy.
• Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
• Subject has mitral or tricuspid valvular regurgitation (>grade III) or moderate to severe mitral stenosis.
• Subject has aortic root angulation >70 degrees (horizontal aorta).
• Subject has a pre-existing prosthetic valve or prosthetic ring in any position.
• Subject refuses blood transfusion or surgical valve replacement.
• Subject has left ventricular ejection fraction (LVEF) < 20%.
• The subject has documented, untreated coronary artery disease (CAD) requiring revascularization.
• Subject has severe basal septal hypertrophy.
• Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days of the index procedure.
• Subject has a history of or has active endocarditis.
• Subject has echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
• Subject has hemodynamic instability (requiring inotropic support or mechanical heart assistance).
• Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
• Subject with significant pulmonary disease.
• Subject has significant chronic steroid use.
• Subject has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
• Subject has renal insufficiency as evidenced by a serum creatinine > 3.0 mg/dL (265µmol/L) or end-stage renal disease requiring chronic dialysis.
• Subject has morbid obesity defined as BMI ≥ 40.
• Subject's iliac arteries have severe calcification, tortuosity (>two 90 degree bends), diameter <6mm, or subject has had an aorto-femoral bypass.
• Subject has ongoing infection or sepsis.
• Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy).
• Subject has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation.
• Subject has significant aortic disease, including:

• aortic abdominal aneurysm (AAA) ≥ 4cm
• thoracic aneurysm (defined as a maximal luminal diameter of 5 cm or greater)
• marked tortuosity
• significant aortic arch atheroma or narrowing of the abdominal or thoracic aorta
• severe tortuosity of the thoracic aorta.
• Subject has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
• Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to the index procedure.
• Subject is currently participating in another investigational drug or device study.
• Subject requires emergency surgery for any reason.
• Subject has a life expectancy < 12 months.
• Subject has other medical, social or psychological conditions that, in the opinion of the Subject Selection Committee, preclude the subject from study participation.
• Subject is suffering from dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.
• Subject has a known allergy to contrast media, nitinol alloys, porcine tissue, or bovine tissue.