Emergency/Compassionate Use PFO Occluder

Expanded access is currently available for this treatment.
Verified July 2016 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00584064
First received: December 20, 2007
Last updated: July 20, 2016
Last verified: July 2016
  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

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

Inclusion Criteria:

  • Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER 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
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 
Study First Received: December 20, 2007
Last Updated: July 20, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 25, 2016