Brief Title
Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
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.
Study Type
Interventional
Primary Outcome
Reporting of Late Adverse Events Relating to the Device.
Condition
Patent Ductus Arteriosus (PDA)
Intervention
Device closure with AMPLATZER Duct Occluder
Study Arms / Comparison Groups
implant to close PDA
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
436
Start Date
October 1999
Completion Date
February 2009
Primary Completion Date
April 2008
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00583596
Organization ID
AGA-004
Secondary IDs
G980103
Responsible Party
Sponsor
Study Sponsor
Abbott Medical Devices
Study Sponsor
, ,
Verification Date
January 2019