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

This study has been completed.
Information provided by:
AGA Medical Corporation Identifier:
First received: December 20, 2007
Last updated: January 31, 2010
Last verified: January 2010

The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus.

Condition Intervention
Device: Device closure with AMPLATZER Duct Occluder
Other: Objective Performance Criteria

AGA Medical Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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 AGA Medical Corporation:

Primary Outcome Measures:
  • The rate of serious and major adverse events will be ≤ 6%. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 441
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: 1 Device: Device closure with AMPLATZER Duct Occluder
Device closure with AMPLATZER Duct Occluder
2 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
Please refer to this study by its identifier: NCT00583596

  Show 24 Study Locations
Sponsors and Collaborators
AGA Medical Corporation
  More Information

No publications provided

Responsible Party: Tammy Benson, AGA Medical Corporation Identifier: NCT00583596     History of Changes
Other Study ID Numbers: AGA-004, G980103
Study First Received: December 20, 2007
Last Updated: January 31, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities processed this record on April 17, 2014