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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00583596
First received: December 20, 2007
Last updated: July 17, 2014
Last verified: June 2014

December 20, 2007
July 17, 2014
October 1999
April 2008   (final data collection date for primary outcome measure)
  • Reporting of Late Adverse Events Relating to the Device. [ Time Frame: Long term follow up for data captured at 5, 6 or 7 years post implant ] [ Designated as safety issue: Yes ]
  • Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure [ Time Frame: Long term follow up data captured at 5, 6 or 7 years post implant ] [ Designated as safety issue: No ]
    The number of participants with a residual shunt (efficacy)
The rate of serious and major adverse events will be ≤ 6%. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00583596 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
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Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
Not Provided

AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus. AGA-007 - The objective of this study is to evaluate the long term safety and effectiveness issues that may not have have been adequately addressed during AGA-004.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Patent Ductus Arteriosus (PDA)
  • 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
Experimental: implant to close PDA
Interventions:
  • Device: Device closure with AMPLATZER Duct Occluder
  • Other: Objective Performance Criteria
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
436
February 2009
April 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00583596
AGA-004, G980103
Yes
AGA Medical Corporation
AGA Medical Corporation
Not Provided
Not Provided
AGA Medical Corporation
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP