Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage
NCT ID: NCT00841529
Last Updated: 2012-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
40 participants
INTERVENTIONAL
2009-03-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Medtronic LAA Occlusion Device
Placement of the occlusion band on the LAA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick McCarthy, MD
Role: STUDY_CHAIR
Northwestern University
Locations
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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
Countries
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Other Identifiers
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D02940
Identifier Type: -
Identifier Source: org_study_id