assessment of the st. jude medical porticotm re-sheathable aortic valve system - alternative access

Conditions: Symptomatic Aortic Stenosis

Summary: the purpose of this clinical investigation is to evaluate the use of the portico alc delivery system to place a transcatheter aortic valve through an alternative access site, specifically subclavian/axillary or tao.


Eligibility criteria:
inclusion criteria: * subject has provided written informed consent. * 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 diameter meets the range indicated in the instructions for use as measured by multislice ct conducted within 120 days prior to the index procedure. * subject has senile degenerative aortic stenosis with echocardiography within 30 days of index procedure as defined by at least 1 of the following: * derived mean gradient greater than 40 mmhg, or * jet velocity greater than 4.0 m/s, or * aortic valve area of less than 0.8 cm2, or * aortic valve area index less than or equal to 0.6 cm2/m2. * subject has symptomatic aortic stenosis as demonstrated by nyha functional classification of ii, iii, or iv. * subject is deemed high operable risk and delivery route is 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. 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. * evidence of an acute myocardial infarction (mi) within 30 days prior to patient providing consent (defined as: st segment elevation as evidenced on 12 lead ecg). * 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 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%. * 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 of 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 significant pulmonary disease as determined and documented by the investigator. * subject has significant chronic steroid use as determined and documented by the investigator. * 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 blood dyscrasias (eg, leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy). * subject has a current autoimmune disease that, in the opinion of the principal investigator or the subject selection committee, precludes the subject from study participation. * significant ascending aortic disease documented by diameter greater than 40mm. * 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. * subject requires emergency surgery for any reason. * subject has a life expectancy less than 12 months. * 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 dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits. * 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. * evidence of an acute myocardial infarction (mi) within 30 days prior to patient providing consent (defined as: st segment elevation as evidenced on 12 lead ecg). * 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 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%. * subject has documented, untreated symptomatic coronary artery disease (cad) requiring revascularization. * cardiovascular or peripheral vascular procedure less than or equal to 14 days of 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 significant pulmonary disease as determined and documented by the investigator. * subject has significant chronic steroid use as determined and documented by the investigator. * 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 blood dyscrasias (eg, leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy). * significant ascending aortic disease documented by diameter greater than 40mm. * 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. * subject requires emergency surgery for any reason. * subject has a life expectancy less than 12 months. * 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 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 documented allergy to contrast media, nitinol alloys, porcine tissue, or bovine tissue.