Clinical trial NCT02088021: Assessment of the St. Jude Medical PorticoTM Re-sheathable Aortic Valve System - Alternative Access
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Symptomatic Aortic Stenosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Major Vascular Complications related to the Portico ALC Delivery System
timeFrame: 30 day post procedure
measure: All cause mortality
timeFrame: 30 day post procedure
Secondary outcomes:
measure: Event Rates
timeFrame: 30 days post procedure
measure: Functional improvement from baseline
timeFrame: 30 days post procedure
measure: Acute device success
timeFrame: 12 months post procedure
Other outcomes:
Locations:
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Axel Linke, Prof Dr. med
role: PRINCIPAL_INVESTIGATOR
References: