Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 2/13/2019 |
Start Date: | October 1999 |
End Date: | February 2009 |
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.
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
We found this trial at
24
sites
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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601 Children's Lane
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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340 W 10th St #6200
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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