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

Abbott

Status: Completed

Conditions: Patent Ductus Arteriosus (PDA)

Treatments: Other: Objective Performance Criteria; Device: Device closure with AMPLATZER Duct Occluder

Study type: Interventional

Funder types: Industry

Identifiers

NCT00583596

AGA-004

G980103

Details and patient eligibility

About

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.

Enrollment: 436 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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436 participants in 1 patient group

implant to close PDA

Experimental group

Treatment:

Other: Objective Performance Criteria

Device: Device closure with AMPLATZER Duct Occluder