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Emergency/Compassionate Use PFO Occluder

Expanded access is currently available for this treatment.
Verified July 2016 by St. Jude Medical
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584064
First Posted: January 2, 2008
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
  Purpose
Emergency/compassionate use for the AMPLATZER PFO Occluder

Condition Intervention
Patent Foramen Ovale PFO 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
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER PFO Access Registry.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584064


Contacts
Contact: Jeff Mifek jmifek@sjm.com

Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00584064     History of Changes
Other Study ID Numbers: AGA-006 - E/C
First Submitted: December 20, 2007
First Posted: January 2, 2008
Last Update Posted: July 21, 2016
Last Verified: July 2016

Keywords provided by St. Jude Medical:
patent
foramen
ovale
PFO

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