Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

PFO ACCESS Registry

Expanded access is currently available for this treatment.
Verified July 2016 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00583401
First received: December 21, 2007
Last updated: July 20, 2016
Last verified: July 2016

December 21, 2007
July 20, 2016
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Complete list of historical versions of study NCT00583401 on ClinicalTrials.gov Archive Site
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PFO ACCESS Registry
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
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.
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.
Expanded Access
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  • Patent Foramen Ovale
  • Stroke
Device: Device closure with the AMPLATZER PFO Occluder
Device closure with the AMPLATZER PFO Occluder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available
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Inclusion Criteria:

  • Patent foramen ovale-(PFO)
  • recurrent 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)
Both
Child, Adult, Senior
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Contact: Karen Cook kcook@sjm.com
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NCT00583401
AGA-011, G060145
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St. Jude Medical
St. Jude Medical
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St. Jude Medical
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP