Status:
TERMINATED
Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Left Atrial Appendage Occlusion
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00841529
Start Date
March 1 2009
End Date
June 1 2010
Last Update
October 23 2012
Active Locations (5)
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1
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
3
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
4
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120