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.

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.