Emergency/Compassionate Use - AMPLATZER Duct Occluder

Expanded access is no longer available for this treatment.

First Received: December 20, 2007 Last Updated: December 28, 2007 History of Changes

Sponsored by:	AGA Medical Corporation
Information provided by:	AGA Medical Corporation
ClinicalTrials.gov Identifier:	NCT00583583

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

Further study details as provided by AGA Medical Corporation:

Intervention Details:

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

No Contacts or Locations Provided

More Information

Additional Information:

FDA PMA Approval This link exits the ClinicalTrials.gov site

No publications provided

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

Study placed in the following topic categories:

Emergencies

ClinicalTrials.gov processed this record on May 07, 2009