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PFO ACCESS Registry

Expanded access is currently available for this treatment.
Verified January 2013 by AGA Medical Corporation
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00583401
First received: December 21, 2007
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Patent Foramen Ovale
Stroke
 Device: Device closure with the AMPLATZER PFO Occluder

Study Type: Expanded Access     What is Expanded Access?

Further study details as provided by AGA Medical Corporation:

Intervention Details:
    Device: Device closure with the AMPLATZER PFO Occluder
    Device closure with the AMPLATZER PFO Occluder
  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • PFO
  • recurrent stroke
  • failed antiplatelet/anticoagulant therapy

Exclusion Criteria:

  • INR outside of 2-3 intracardiac thrombus (subjects may be enrolled after resultion of thrombus)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583401

Contacts
Contact: Janet Larson Jlarson@sjm.com

Sponsors and Collaborators
AGA Medical Corporation
  More Information

No publications provided

Responsible Party: AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00583401     History of Changes
Obsolete Identifiers: NCT00557479
Other Study ID Numbers: AGA-011, G060145
Study First Received: December 21, 2007
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:
PFO
stroke

Additional relevant MeSH terms:
Foramen Ovale, Patent
Heart Septal Defects, Atrial
Stroke
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
 Heart Diseases
Congenital Abnormalities
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013