Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:February 2009
End Date:August 2010

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The purpose of this study is to evaluate the performance of the Cardioblate Closure Device
to occlude the LAA


Inclusion Criteria:

- Subject is greater than or equal to 18 years of age and less than or equal to 80
years of age

- Concomitant indication for cardiac surgery for one or more of the following:mitral
valve repair or replacement, aortic valve repair or replacement, tricuspid valve
repair or replacement CABG (>=60 years of age), CABG (< 60 years of age with a
history of atrial fibrillation), surgical ablation or Maze procedure

- The subject is willing and able to provide written informed consent and comply with
study requirements

- The subject is not contra-indicated for intra-operative transesophageal
echocardiogram (TEE)

Exclusion Criteria:

- Thrombus in the LAA and/or left atrium

- Prior LAA isolation attempts

- Subject is unable to take an anticoagulant during the study follow-up period

- Subject is undergoing an emergency cardiac procedure

- Life expectancy of less than 12 months

- Pregnancy or desire to be pregnant within the 12 months of the study procedure
We found this trial at
5
sites
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Milwaukee, WI
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Oklahoma City, Oklahoma 73120
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Oklahoma City, OK
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Palm Springs, California 92270
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Palm Springs, CA
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