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

Completed · Not applicable

Conditions studied: Patent Ductus Arteriosus (PDA)

In brief

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.

Key facts

Study ID

NCT00583596

Run by

Abbott Medical Devices

People needed

436

Starts

1999-10-01

Expected to finish

2009-02-01

Last updated by the study team

2023-06-29

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a demonstrated patent ductus arteriosus
• Body weight > 5 Kilograms

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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