Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System (Portico TA EU)
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The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis
Vascular access site and Access-related complications
Composite of periprocedural encephalopathy, all stroke, and all TIA
Functional improvements from baseline [ Time Frame: 30 days ]
NYHA Functional Classification
Six Minute Walk Test
Effective Orifice Area (EOA)
Acute device success [ Time Frame: At time of procedure ]
Successful apical access, delivery and deployment of the device and successful retrieval of the delivery system,
Correct position of the device in the proper anatomical location,
Intended performance of the prosthetic heart valve (Aortic Valve Area greater than (>)1.0 cm2 and mean aortic valve gradient less than (<) 20 mmHg or peak velocity less than (<) 3 m/s, without moderate or severe prosthetic valve AR), and
Only one valve implanted in the proper anatomical location
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Ages Eligible for Study:
65 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subject has signed the study Informed Consent Form and Data Protection Form prior to participating in the study.
Subject is 65 years of age or older at the time of index procedure, and/or has comorbidities that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude surgical valve replacement.
Subject's aortic annulus is 19-21mm diameter as measured by echocardiography (echo) or CT conducted within 90 days prior to the index procedure.
Subject has senile degenerative aortic stenosis with echocardiography derived mean gradient greater than (>) 40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of less than (<) 0.8 cm2 (or aortic valve area index less than or equal to (≤) 0.6 cm2/m2). (Baseline measurement taken by echo within 90 days of index procedure).
Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
Subject is deemed high operable risk and suitable for TAVI per the medical opinion of the Subject Selection Committee.
Subject's predicted operative mortality or serious, irreversible morbidity risk is less than (<) 50% at 30 days post index procedure.
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 a chest condition than prevents transapical access.
Subject has carotid artery disease requiring intervention.
Subject has documented evidence of a myocardial infarction (MI) within 6 months (less than or equal to (≤) 180 days) prior to the index procedure.
Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
Subject has mitral valvular regurgitation greater than (>) grade III.
Subject has moderate or severe mitral stenosis.
Subject has aortic root angulation greater than (>) 70 degrees (horizontal aorta).
The distance from the left ventricular apex to the aortic annulus is less than (<) 45mm (4.5cm).
Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position.
Subject refuses any blood product transfusion.
Subject refuses surgical valve replacement.
Subject has left ventricular ejection fraction (LVEF) less than (<) 20%.