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

NCT ID: NCT02088021

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Symptomatic Aortic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Portico Transcatheter Aortic Valve Implantation

Placement of the SJM Portico aortic valve with a ALC delivery system

Group Type: EXPERIMENTAL

Portico Transcatheter Aortic Valve

Intervention Type: DEVICE

Placement of the SJM Portico aortic valve with a ALC delivery system

Interventions

Portico Transcatheter Aortic Valve

Placement of the SJM Portico aortic valve with a ALC delivery system

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Axel Linke, Prof Dr. med

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig - University Hospital

Other Identifiers

CL07045

Identifier Type: -

Identifier Source: org_study_id