Atrial Fibrillation Clinical Trial
Official title:
Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation: Latin America Registry on WatchmanTM Outcomes in Real Life
Left atrial appendage (LAA) occlusion with WatchmanTM has emerged as viable alternative to anticoagulation therapy in randomized controlled trials. The device has FDA approved since 2015 and the firsts Latin American cases were performed in 2012. However, there is no real world data from Latin American experience in terms of success and outcomes.
Approximately 450 subjects will be enrolled in the study. Up to 50 sites in Latin America
will participate in the study.
Primary analyses may include, but will not be limited to, the following: procedural
complications, incidence of stroke and death. Descriptive statistics will be used for
baseline, procedure and follow-up data collected through the registry.
Clinical history of each patient will be analyzed for a period of 6 months after the
procedure according the standard practice at the enrolling centers. There will be no
additional visits, nor procedures, for subjects in the registry.
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