This Continued Access Protocol is a prospective, non-randomized, multicenter study to allow continued access to the WATCHMAN LAA Closure Technology during the data analysis, reporting and review of the PREVAIL pivotal study Pre-Market Application by FDA.
Subjects with non-valvular AF who require treatment for potential thrombus formation, and are eligible for warfarin therapy, will be screened to participate in the study. Subjects will be screened via review of medical history, transthoracic echocardiography (TTE) and TEE testing. Once study eligibility is determined, subjects will be enrolled and implanted with the WATCHMAN device. After implant, subjects will receive warfarin therapy until TEE imaging has confirmed adequate sealing of the LAA. Successfully implanted subjects will be followed post enrollment for assessment of adverse events at intervals of 45 days, 6 months, 12 months, semi-annually through 3 years, and thereafter annually through 5 years.