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Emergency/Compassionate Use PFO Occluder

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00584064
Expanded Access Status : Approved for marketing
First Posted : January 2, 2008
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
Emergency/compassionate use for the AMPLATZER PFO Occluder

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

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Study Type : Expanded Access

Resource links provided by the National Library of Medicine



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

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.

No Contacts or Locations Provided
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00584064    
Other Study ID Numbers: AGA-006 - E/C
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Keywords provided by Abbott Medical Devices:
patent
foramen
ovale
PFO
Additional relevant MeSH terms:
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Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities