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Expanded access is currently available for this treatment.
Verified August 2014 by AGA Medical Corporation
Information provided by (Responsible Party):
AGA Medical Corporation Identifier:
First received: December 21, 2007
Last updated: August 20, 2014
Last verified: August 2014

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
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

Genders Eligible for Study:   Both

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00583401

Contact: Karen Cook

Sponsors and Collaborators
AGA Medical Corporation
  More Information

No publications provided

Responsible Party: AGA Medical Corporation Identifier: NCT00583401     History of Changes
Obsolete Identifiers: NCT00557479
Other Study ID Numbers: AGA-011, G060145
Study First Received: December 21, 2007
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:

Additional relevant MeSH terms:
Foramen Ovale, Patent
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Heart Septal Defects
Heart Septal Defects, Atrial processed this record on November 27, 2014