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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
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 ]
  • 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 ]
    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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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.

Please refer to this study by its identifier: NCT00583596

  Show 24 Study Locations
Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical Identifier: NCT00583596     History of Changes
Other Study ID Numbers: AGA-004
Study First Received: December 20, 2007
Results First Received: January 17, 2014
Last Updated: January 28, 2015

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

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities processed this record on April 28, 2017