Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
Macon Medical Center
Macon, Georgia, United States
St. Francis Heart Hospital
Indianapolis, Indiana, United States
Spectrum Health
Grand Rapids, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Rate of Device Related Serious Adverse Events
The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.
Time frame: Discharge/30 days Post Procedure
Percent of Patients With Complete Occlusion of the Left Atrial Appendage.
The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.
Time frame: 3 Months Post Procedure
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Mount Carmel East Hospital
Columbus, Ohio, United States
Baylor Heart Hospital
Plano, Texas, United States
University of Virginia
Charlottesville, Virginia, United States