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PFO ACCESS Registry

Sponsor
Abbott Medical Devices (Industry)
Overall Status
No longer available
CT.gov ID
NCT00583401
Collaborator
(none)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Device closure with the AMPLATZER PFO Occluder

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.

Study Design

Study Type:
Expanded Access
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT00583401
    Other Study ID Numbers:
    • AGA-011
    • G060145
    • NCT00557479
    First Posted:
    Dec 31, 2007
    Last Update Posted:
    Feb 4, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Abbott Medical Devices
    PFO
    stroke
    Additional relevant MeSH terms:
    Stroke
    Foramen Ovale, Patent

    Study Results

    No Results Posted as of Feb 4, 2019