Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage
Stopped early · Phase 2
Conditions studied: Left Atrial Appendage Occlusion
In brief
The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA
Key facts
- Study ID
- NCT00841529
- Run by
- Medtronic Cardiovascular
- People needed
- 40
- Starts
- 2009-03-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2012-10-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Eisenhower Medical Center — Rancho Mirage, California, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
- Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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