Primary Safety Endpoint The primary safety endpoint is the incidence of major adverse events up to 45 days post-procedure. Major adverse events are defined as life-threatening incidents as determined by the Clinical Events Committee (CEC) and include events such as device embolization; cardiac injury, re-intervention, and/or device-related surgery; bleeding events such as pericardial effusion requiring drainage, cranial bleeding due to any source, gastrointestinal bleeding; or any other event related to the device or the procedure, which requires treatment.