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PFO ACCESS Registry

Primary Purpose

Patent Foramen Ovale, Stroke

Status
No longer available
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 PFO, stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

Patent foramen ovale (PFO); recurrent cryptogenic stroke; failed antiplatelet/anticoagulant therapy

Exclusion Criteria:

International normalized ration (INR) outside of 2-3; intracardiac thrombus (subjects may be enrolled after resolution of thrombus)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 21, 2007
    Last Updated
    January 31, 2019
    Sponsor
    Abbott Medical Devices
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00583401
    Brief Title
    PFO ACCESS Registry
    Official Title
    Patent Foramen Ovale Closure With the AMPLATZER PFO OCCLUDER in Patients With Recurrent Cryptogenic Stroke Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale Who Have Failed Conventional Drug Therapy
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    No longer available
    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
    Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.
    Detailed Description
    The primary objective of the PFO Access Registry is to allow access to the AMPLATZER PFO Occluder in subjects with a PFO who have already experienced at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional drug therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patent Foramen Ovale, Stroke
    Keywords
    PFO, stroke

    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
    Eligibility Criteria
    Inclusion Criteria: Patent foramen ovale (PFO); recurrent cryptogenic stroke; failed antiplatelet/anticoagulant therapy Exclusion Criteria: International normalized ration (INR) outside of 2-3; intracardiac thrombus (subjects may be enrolled after resolution of thrombus)

    12. IPD Sharing Statement

    Learn more about this trial

    PFO ACCESS Registry

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