Assessment of the St. Jude Medical PorticoTM Re-sheathable Aortic Valve System - Alternative Access
- Conditions
- Symptomatic Aortic Stenosis
- Interventions
- Device: Portico Transcatheter Aortic Valve
- Registration Number
- NCT02088021
- Lead Sponsor
- Abbott Medical Devices
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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Subject has provided written informed consent.
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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.
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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.
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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.
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Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
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Subject is deemed high operable risk and delivery route is suitable for TAVI per the medical opinion of the Subject Selection Committee.
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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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Portico Transcatheter Aortic Valve Implantation Portico Transcatheter Aortic Valve Placement of the SJM Portico aortic valve with a ALC delivery system
- Primary Outcome Measures
Name Time Method All cause mortality 30 day post procedure Major Vascular Complications related to the Portico ALC Delivery System 30 day post procedure
- Secondary Outcome Measures
Name Time Method Event Rates 30 days post procedure 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."Functional improvement from baseline 30 days post procedure Functional improvement from baseline as compared to 30 days by:
* NYHA Functional Classification
* Six Minute Walk Test
* Effective Orifice Area (EOA)Acute device success 12 months post procedure 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