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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00583596
Recruitment Status : Completed
First Posted : December 31, 2007
Results First Posted : July 18, 2014
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
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 or disease Intervention/treatment
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  (Clinical Trial)
Actual Enrollment : 436 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 1999
Primary Completion Date : April 2008
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583596


  Show 24 Study Locations
Sponsors and Collaborators
St. Jude Medical

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00583596     History of Changes
Other Study ID Numbers: AGA-004
G980103
First Posted: December 31, 2007    Key Record Dates
Results First Posted: July 18, 2014
Last Update Posted: February 16, 2015
Last Verified: January 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