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

This study has been completed.
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: December 20, 2007
Last updated: January 28, 2015
Last verified: January 2015
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.

Condition Intervention
Patent Ductus Arteriosus (PDA)
Device: Device closure with AMPLATZER Duct Occluder
Other: Objective Performance Criteria

Access to an investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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)

Enrollment: 436
Study Start Date: October 1999
Study Completion Date: February 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: implant to close 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


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00583596

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Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical Identifier: NCT00583596     History of Changes
Other Study ID Numbers: AGA-004  G980103 
Study First Received: December 20, 2007
Results First Received: January 17, 2014
Last Updated: January 28, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
patent ductus arteriosus (PDA)

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases processed this record on May 01, 2016