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Emergency/Compassionate Use PFO Occluder

Primary Purpose

Patent Foramen Ovale, PFO

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Device closure with the AMPLATZER PFO Occluder
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Patent Foramen Ovale focused on measuring patent, foramen, ovale, PFO

Eligibility Criteria

18 Years - 60 Years (Adult)All Sexes

Inclusion Criteria:

  • Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER PFO Access Registry.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 20, 2007
    Last Updated
    April 9, 2019
    Sponsor
    Abbott Medical Devices
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00584064
    Brief Title
    Emergency/Compassionate Use PFO Occluder
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Abbott Medical Devices

    4. Oversight

    5. Study Description

    Brief Summary
    Emergency/compassionate use for the AMPLATZER PFO Occluder

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patent Foramen Ovale, PFO
    Keywords
    patent, foramen, ovale, PFO

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Device closure with the AMPLATZER PFO Occluder
    Intervention Description
    Device closure with the AMPLATZER PFO Occluder

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Eligibility Criteria
    Inclusion Criteria: Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER PFO Access Registry.

    12. IPD Sharing Statement

    Learn more about this trial

    Emergency/Compassionate Use PFO Occluder

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