Clincosm LogoSign in Get a demo

Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01497418
Collaborator
(none)
2
Enrollment
2
Locations
27
Duration (Months)
1
Patient Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Collect and evaluate the long term safety data.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this study is to collect and evaluate the long term safety data of the 23mm Portico™ Transcatheter Heart Valve and the transfemoral Delivery System previously implanted in subjects with aortic valve disease.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the SJM Transfemoral Delivery System
    Study Start Date :
    Dec 1, 2011
    Actual Primary Completion Date :
    Jul 1, 2012
    Actual Study Completion Date :
    Mar 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. The objective of this study is to retrospectively and prospectively collect and evaluate the long term safety of the 23mm Portico Transcatheter Aortic Heart [1 year]

      Data will be collected at 3 months, 6 months, and 12 months post-implant.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subject has given written study Informed Consent for participation prior to any study procedures.

    2. Subject is ≥ 18 years of age or legal age in host country at time of consent.

    3. Subject currently has a 23mm SJM Portico Transfemoral Transcatheter Heart Valve

    Exclusion Criteria:

    1. Subject currently participating in another investigational device or drug study.

    2. Subject is unable or unwilling to return for the required follow-up visits.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 l'Institut universitaire de cardiologie et de pneumologie de Québec Quebec Canada
    2 St. Paul's Hospital Vancouver Canada

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    • Principal Investigator: John Webb, MD, Providence Health Care - St. Paul's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT01497418
    Other Study ID Numbers:
    • 1102
    First Posted:
    Dec 22, 2011
    Last Update Posted:
    Feb 4, 2019
    Last Verified:
    Feb 1, 2019
    Additional relevant MeSH terms:
    Aortic Valve Stenosis

    Study Results

    No Results Posted as of Feb 4, 2019