PFO ACCESS Registry
Expanded access is currently available for this treatment.
Verified January 2015 by St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
First received: December 21, 2007
Last updated: January 30, 2015
Last verified: January 2015
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.
Patent Foramen Ovale
Device: Device closure with the AMPLATZER PFO Occluder
|Genders Eligible for Study:
- Patent foramen ovale-(PFO)
- recurrent stroke
- failed antiplatelet/anticoagulant therapy
- International normalized ration (INR) outside of 2-3 intracardiac thrombus (subjects may be enrolled after resolution of thrombus)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00583401
St. Jude Medical
No publications provided
||St. Jude Medical
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 21, 2007
||January 30, 2015
||United States: Food and Drug Administration
Keywords provided by St. Jude Medical:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2015
Foramen Ovale, Patent
Heart Defects, Congenital
Heart Septal Defects
Heart Septal Defects, Atrial