Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER



Status:Completed
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:2/6/2019
Start Date:September 2003
End Date:September 2010

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The purpose of this feasibility study is to investigate the safety of the AMPLATZER®
Membranous VSD Occluder for the treatment of hemodynamically significant Perimembranous
Ventricular Septal Defects.


Inclusion Criteria:

- Patients with hemodynamically significant Perimembranous ventricular septal defects

Exclusion Criteria:

- Patients < 8 kg

- Supracristal ventricular septal defects

- Left ventricle to right atrium shunting

- Prolapse of the aortic valve

- Right to left shunting through the defect

- Perimembranous VSD with an aneurysm and multiple shunts which can not be successfully
closed with one device

- Patients with <2mm aortic rim

- Sepsis (local/generalized)

- Complex heart lesions such as atrioventricular canal defect or Tetralogy of Fallot.

- Patients who are ASA intolerant

- Unable to be followed for the duration of the clinical trial

- Inability to obtain informed consent
We found this trial at
6
sites
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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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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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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Columbus, Ohio 43205
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Columbus, OH
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Omaha, Nebraska 68114
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Omaha, NE
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Saint Louis, Missouri 63110
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Saint Louis, MO
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