Emergency/Compassionate Use - AMPLATZER Duct Occluder

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00583583
First received: December 20, 2007
Last updated: December 28, 2007
Last verified: December 2007
  Purpose

Emergency/compassionate use for the AMPLATZER Duct Occluder


Condition Intervention
Patent
Ductus
Arteriosus
Device: Device closure with the AMPLATZER Duct 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 Duct Occluder
    Device closure with the AMPLATZER Duct Occluder
  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Emergency/compassionate use for patients not meeting the inclusion crtieria for the AMPLATZER Duct Occluder clinical trial
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ken Lock, AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00583583     History of Changes
Other Study ID Numbers: AGA-004 E/C, G980103
Study First Received: December 20, 2007
Last Updated: December 28, 2007
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 26, 2014