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Completed Not applicable Interventional Results available

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

ClinicalTrials.gov ID: NCT00583596

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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT00583596. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 15, 2026, 1:37 AM EST

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00583596
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Abbott Medical Devices
Industry
Enrollment
436 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 Months to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 1999 (Type not available)
Primary completion
Apr 2008 (Actual)
Completion
Feb 2009 (Actual)
Last update posted
Jun 29, 2023

1999 – 2009

United States locations

U.S. sites
24
U.S. states
20
U.S. cities
24
Facility City State ZIP Site status
University of Alabama Birmingham Alabama 35294 —
Children's Hospital San Diego California 92123 —
Children's Hospital Denver Colorado 80218 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
University of Florida Gainesville Florida 32610 —
Arnold Palmer Hospital Orlando Florida 32806 —
University of Chicago Chicago Illinois 60637 —
Indiana University School of Medicine Indianapolis Indiana 46202 —
Louisana State University Medical Center New Orleans Louisiana 70112 —
New England Medical Center Boston Massachusetts 02111 —
University of Minnesota Minneapolis Minnesota 55455 —
Mayo Clinic Rochester Minnesota 55905 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
Washington University Medical Center St Louis Missouri 63110 —
Children's Hospital UN/CU) Omaha Nebraska 68114 —
Columbia University New York New York 10032 —
Childrens Hospital Rochester New York 14642 —
University of North Carolina Chapel Hill North Carolina 27599 —
Medical University of South Carolina Charleston South Carolina 29425 —
University of Texas Dallas Texas 75235 —
Cook Children's Heart Center Fort Worth Texas 76104 —
Children's Hospital of the King's Daughters Norfolk Virginia 30322 —
University of Washington Medical Center Seattle Washington 98195 —
Children's Hospital of Wisconsin Milwaukee Wisconsin 53201 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00583596, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 29, 2023 · Synced Nov 15, 2026

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