Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder

This study has been completed.

Sponsor:

Information provided by:

AGA Medical Corporation

ClinicalTrials.gov Identifier:

NCT00583596

First received: December 20, 2007

Last updated: January 31, 2010

Last verified: January 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	December 20, 2007
Last Updated Date	January 31, 2010
Start Date ^ICMJE	October 1999
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 21, 2007)	The rate of serious and major adverse events will be ≤ 6%. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00583596 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 21, 2007)	The residual patency rate is expected to be < 15% by Doppler color flow mapping and <5% by clinical exam. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
Official Title ^ICMJE	Not Provided
Brief Summary	The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Patent Ductus Arteriosus PDA
Intervention ^ICMJE	Device: Device closure with AMPLATZER Duct Occluder Device closure with AMPLATZER Duct Occluder Other: Objective Performance Criteria Compare results of device closure to objective performance criteria
Study Arm (s)	Experimental: 1 Intervention: Device: Device closure with AMPLATZER Duct Occluder 2 Intervention: Other: Objective Performance Criteria
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	441
Completion Date	February 2009
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with a demonstrated patent ductus arteriosus Body weight > 5 Kilograms Exclusion Criteria: Pulmonary vascular resistance above 8 Woods units or a Rp/Rs >0.4. Additional cardiac or non-cardiac abnormality that can reasonably be expected to significantly affect the patient's health adversely in the next two years, i.e.: cancer, Eisenmenger's syndrome, other serious congenital heart disease. Pelvic vein or inferior vena cava thrombosis Sepsis (local/generalized) or any type of infection that cannot be successfully treated prior to device placement. History of repeated pulmonary infection Demonstrated intracardiac thrombi on echocardiography • Inability to obtain informed consent
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00583596
Other Study ID Numbers ^ICMJE	AGA-004, G980103
Has Data Monitoring Committee	Yes
Responsible Party	Tammy Benson, AGA Medical Corporation
Study Sponsor ^ICMJE	AGA Medical Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AGA Medical Corporation
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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