Assessment of the St. Jude Medical PorticoTM Re-sheathable Aortic Valve System - Alternative Access

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.