Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

PFO ACCESS Registry

Expanded access is currently available for this treatment.
Verified January 2015 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00583401
First received: December 21, 2007
Last updated: January 30, 2015
Last verified: January 2015

December 21, 2007
January 30, 2015
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Complete list of historical versions of study NCT00583401 on ClinicalTrials.gov Archive Site
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PFO ACCESS Registry
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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.

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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
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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
January 2015

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