Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
NCT ID: NCT00583596
Last Updated: 2023-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
436 participants
INTERVENTIONAL
1999-10-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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implant to close PDA
Device closure with AMPLATZER Duct Occluder
Device closure with AMPLATZER Duct Occluder
Objective Performance Criteria
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Interventions
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Device closure with AMPLATZER Duct Occluder
Device closure with AMPLATZER Duct Occluder
Objective Performance Criteria
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Eligibility Criteria
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Inclusion Criteria
* Body weight \> 5 Kilograms
Exclusion Criteria
* 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
6 Months
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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University of Alabama
Birmingham, Alabama, United States
Children's Hospital
San Diego, California, United States
Children's Hospital
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Arnold Palmer Hospital
Orlando, Florida, United States
University of Chicago
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Louisana State University Medical Center
New Orleans, Louisiana, United States
New England Medical Center
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University Medical Center
St Louis, Missouri, United States
Children's Hospital UN/CU)
Omaha, Nebraska, United States
Columbia University
New York, New York, United States
Childrens Hospital
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas
Dallas, Texas, United States
Cook Children's Heart Center
Fort Worth, Texas, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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G980103
Identifier Type: -
Identifier Source: secondary_id
AGA-004
Identifier Type: -
Identifier Source: org_study_id
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