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 |
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
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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