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PFO ACCESS Registry

Expanded access is currently available for this treatment.
Verified July 2016 by St. Jude Medical
Sponsor:
ClinicalTrials.gov Identifier:
NCT00583401
First Posted: December 31, 2007
Last Update Posted: July 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
December 21, 2007
December 31, 2007
July 21, 2016
 
PFO ACCESS Registry
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
Device: Device closure with the AMPLATZER PFO Occluder
Device closure with the AMPLATZER PFO Occluder
Not Provided
 
Available
Contact: Karen Cook kcook@sjm.com
Not Provided
 
 
NCT00583401
St. Jude Medical
St. Jude Medical
Not Provided
Not Provided
St. Jude Medical
July 2016