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PFO ACCESS Registry

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ClinicalTrials.gov Identifier: NCT00583401
Recruitment Status : No longer available
First Posted : December 31, 2007
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
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 or disease Intervention/treatment
Patent Foramen Ovale Stroke Device: Device closure with the AMPLATZER PFO Occluder

Detailed Description:
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.

Study Type : Expanded Access
Official Title: 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

Intervention Details:
    Device: Device closure with the AMPLATZER PFO Occluder
    Device closure with the AMPLATZER PFO Occluder

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

Patent foramen ovale (PFO); recurrent cryptogenic 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)


No Contacts or Locations Provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00583401     History of Changes
Obsolete Identifiers: NCT00557479
Other Study ID Numbers: AGA-011
G060145
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018

Keywords provided by St. Jude Medical:
PFO
stroke

Additional relevant MeSH terms:
Stroke
Foramen Ovale, Patent
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities