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

Not Applicable

Completed

Conditions: Patent Ductus Arteriosus (PDA)

Interventions: Device: Device closure with AMPLATZER Duct Occluder
Other: Objective Performance Criteria

Registration Number: NCT00583596

Lead Sponsor: Abbott Medical Devices

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 436

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
implant to close PDA	Objective Performance Criteria	-
implant to close PDA	Device closure with AMPLATZER Duct Occluder	-

Primary Outcome Measures

Name	Time	Method
Reporting of Late Adverse Events Relating to the Device.	Long term follow up for data captured at 5, 6 or 7 years post implant
Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure	Long term follow up data captured at 5, 6 or 7 years post implant	The number of participants with a residual shunt (efficacy)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (23): University of Chicago
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Chicago, Illinois, United States
University of Texas
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Dallas, Texas, United States
Children's National Medical Center
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Washington, District of Columbia, United States
University of Mississippi Medical Center
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Jackson, Mississippi, United States
Washington University Medical Center
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Saint Louis, Missouri, United States
Columbia University
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New York, New York, United States
Childrens Hospital
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Rochester, New York, United States
Children's Hospital of the King's Daughters
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Norfolk, Virginia, United States
University of Florida
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Gainesville, Florida, United States
Cook Children's Heart Center
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Fort Worth, Texas, United States
University of Alabama
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Birmingham, Alabama, United States
Arnold Palmer Hospital
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Orlando, Florida, United States
Medical University of South Carolina
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Charleston, South Carolina, United States
Children's Hospital
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Denver, Colorado, United States
Indiana University School of Medicine
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Indianapolis, Indiana, United States
New England Medical Center
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Boston, Massachusetts, United States
Louisana State University Medical Center
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New Orleans, Louisiana, United States
University of Minnesota
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Minneapolis, Minnesota, United States
Mayo Clinic
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Rochester, Minnesota, United States
Children's Hospital UN/CU)
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Omaha, Nebraska, United States
University of Washington Medical Center
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Seattle, Washington, United States
Children's Hospital of Wisconsin
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Milwaukee, Wisconsin, United States
University of North Carolina
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Chapel Hill, North Carolina, United States