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Emergency/Compassionate Use PFO Occluder

Expanded access is currently available for this treatment.
Verified July 2016 by St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: December 20, 2007
Last updated: July 20, 2016
Last verified: July 2016
Emergency/compassionate use for the AMPLATZER PFO Occluder

Condition Intervention
Patent Foramen Ovale
Device: Device closure with the AMPLATZER PFO Occluder

Study Type: Expanded Access     What is Expanded Access?

Further study details as provided by St. Jude Medical:

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

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER PFO Access Registry.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00584064

Contact: Jeff Mifek

Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical Identifier: NCT00584064     History of Changes
Other Study ID Numbers: AGA-006 - E/C
Study First Received: December 20, 2007
Last Updated: July 20, 2016

Keywords provided by St. Jude Medical:

Additional relevant MeSH terms:
Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities processed this record on May 23, 2017