Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System

NCT01742598 | Withdrawn DMC

• 1 other identifier: 1106
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis

Conditions

Severe Symptomatic Aortic Stenosis

Keywords

TAVI; TAVR; aortic stenosis; Transcatheter; valvular heart disease; aortic valve stenosis; aortic valve replacement; transcatheter aortic valve implantation

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  30 days

Secondary Outcomes (3)

• Event rates

  30 days

• Functional improvements from baseline

  30 days

• Acute device success

  At time of procedure

Study Arms (1)

Portico Implant

EXPERIMENTAL

Device: Portico Transapical Aortic Valve System

Interventions

Portico Transapical Aortic Valve System DEVICE

Portico Implant

Eligibility Criteria

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

You may qualify if:

• Subject has signed the study Informed Consent Form and Data Protection Form prior to participating in the study.
• 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 is 19-21mm diameter as measured by echocardiography (echo) or CT conducted within 90 days prior to the index procedure.
• Subject has senile degenerative aortic stenosis with echocardiography derived mean gradient greater than (\>) 40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of less than (\<) 0.8 cm2 (or aortic valve area index less than or equal to (≤) 0.6 cm2/m2). (Baseline measurement taken by echo within 90 days of index procedure).
• Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
• Subject is deemed high operable risk and 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 a chest condition than prevents transapical access.
• Subject has carotid artery disease requiring intervention.
• Subject has documented evidence of a myocardial infarction (MI) within 6 months (less than or equal to (≤) 180 days) prior to the index procedure.
• 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 aortic root angulation greater than (\>) 70 degrees (horizontal aorta).
• The distance from the left ventricular apex to the aortic annulus is less than (\<) 45mm (4.5cm).
• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

King's College Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Thomas Walther, MD, PhD

  Kerckhoff Klinik

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 5, 2012
• Study Start: December 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2020
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

GB (1)