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Emergency/Compassionate Use PFO Occluder

Expanded access is currently available for this treatment.
Verified September 2014 by AGA Medical Corporation
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00584064
First received: December 20, 2007
Last updated: September 29, 2014
Last verified: September 2014
  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 AGA Medical Corporation:

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER PFO Occluder RESPECT trial or PFO Access Registry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584064

Contacts
Contact: Jeff Mifek jmifek@sjm.com

Sponsors and Collaborators
AGA Medical Corporation
  More Information

No publications provided

Responsible Party: AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00584064     History of Changes
Other Study ID Numbers: AGA-006 - E/C
Study First Received: December 20, 2007
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:
patent
foramen
ovale
PFO

ClinicalTrials.gov processed this record on November 20, 2014