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

NCT02088021 | Withdrawn DMC

• 1 other identifier: CL07045
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Major Vascular Complications related to the Portico ALC Delivery System

  30 day post procedure

• All cause mortality

  30 day post procedure

Secondary Outcomes (3)

• Event Rates

  30 days post procedure

• Functional improvement from baseline

  30 days post procedure

• Acute device success

  12 months post procedure

Study Arms (1)

Portico Transcatheter Aortic Valve Implantation

EXPERIMENTAL

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

Device: Portico Transcatheter Aortic Valve

Interventions

Portico Transcatheter Aortic Valve DEVICE

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

Portico Transcatheter Aortic Valve Implantation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Officials

• Axel Linke, Prof Dr. med

  Heart Center Leipzig - University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 14, 2014
• Study Start: January 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 4, 2019

Record last verified: 2019-02