Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
- Conditions
- Patent Ductus Arteriosus (PDA)
- 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
- Patients with a demonstrated patent ductus arteriosus
- Body weight > 5 Kilograms
- 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
- 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 Alabama
🇺🇸Birmingham, Alabama, United States
Children's Hospital
🇺🇸Denver, Colorado, United States
Children's National Medical Center
🇺🇸Washington, 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
Scroll for more (13 remaining)University of Alabama🇺🇸Birmingham, Alabama, United States