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

Study Overview
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Brief Summary
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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.

Conditions
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Symptomatic Aortic Stenosis

Intervention / Treatment
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* Device: Portico Transcatheter Aortic Valve


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Portico Transcatheter Aortic Valve Implantation<br>Placement of the SJM Portico aortic valve with a ALC delivery system | Device: Portico Transcatheter Aortic Valve<br>* Placement of the SJM Portico aortic valve with a ALC delivery system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Vascular Complications related to the Portico ALC Delivery System |  | 30 day post procedure | 
| All cause mortality |  | 30 day post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Rates | Event rates as described by VARC-2 Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document European Heart Journal (2012) 33, 2403-2418. | 30 days post procedure | 
| Functional improvement from baseline | Functional improvement from baseline as compared to 30 days by: NYHA Functional Classification Six Minute Walk Test Effective Orifice Area (EOA) | 30 days post procedure | 
| Acute device success | Acute device success defined as: Ability of the Portico ALC Delivery System to successfully deliver, deploy, and resheath (if necessary) a transcatheter aortic valve Absence of procedural mortality Correct positioning of a single prosthetic heart valve into the proper anatomical location Intended performance of the prosthetic heart valve, as defined by: mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, and no moderate or severe prosthetic valve regurgitation | 12 months post procedure |