All sites will monitored regularly during the time of the registry. The monitor plan involves a hundred percent procedural information and event monitoring. During data monitoring, all source data will be assessed for accuracy, completeness, and representativeness of registry data by comparing the data to external data sources. Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry are implemented in the (eCRF). A data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used, and normal ranges if relevant is part of the database and eCRF design. Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management are in place. A detailed statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol is available. Missing data is accounted for in the design of the eCRF template, and will be handled according to the statistical plan.