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

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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
We found this trial at
24
sites
340 W 10th St #6200
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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Indianapolis, IN
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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Norfolk, VA
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Birmingham, Alabama 35294
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Birmingham, AL
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Boston, Massachusetts 02111
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Boston, MA
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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171 Ashley Avenue
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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Charleston, SC
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Dallas, Texas 75235
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Dallas, TX
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Denver, Colorado 80218
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Denver, CO
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Fort Worth, Texas 76104
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Fort Worth, TX
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9000 W Wisconsin Ave #270
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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Milwaukee, WI
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New Orleans, Louisiana 70112
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New Orleans, LA
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Omaha, Nebraska 68114
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Omaha, NE
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Orlando, Florida 32806
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Orlando, FL
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Rochester, Minnesota 55905
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Rochester, MN
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Rochester, New York 14642
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Rochester, NY
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Saint Louis, Missouri 63110
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Saint Louis, MO
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San Diego, California 92123
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San Diego, CA
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Seattle, WA
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111 Michigan Ave NW
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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from
Washington,
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