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

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.

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