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STAR Apollo™ Mapping System assists users in manual annotation of 3D anatomical and electrical maps of human atria using data from multipolar, intracardiac, atrial, electrograms during atrial fibrillation. The clinical significance of utilizing the STAR Apollo Mapping System, to help identify areas with intracardiac atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The STAR Apollo 100 Mapping System is a software driven system designed to assist operators in identifying Early Site of Activations (ESA) and Repetitive Patterns of Activation (RPA) in patients undergoing a cardiac mapping procedure for Atrial Fibrillation (AF). The software is designed for use in association with a commercially approved electroanatomic mapping system, specifically, Ensite Precision Cardiac Mapping System Model EE 3000 (V2.6) or Ensite X EP System (V 1.1.1) (Abbott Medical), and the commercially approved catheter, Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (Abbott Medical). The system consists of proprietary Star Apollo Mapping System software and a hardware component. Star Apollo Mapping System software consists of 3 main components: Electroanatomic data import, the STAR Apollo Mapping System engine (C++ code) and Graphics User Interface (GUI). The STAR Apollo Mapping System is designed to run on a laptop computer running Windows 10 or later operating system. Star Apollo Mapping System software is pre-installed onto the laptop. The STAR Apollo Mapping System uses export data from the Ensite Precision or Ensite X EP system that has been collected with the HD Grid catheter during the mapping procedure. The HD Grid is used to collect anatomy, localization and electrogram data in the atria. Recordings are made for 30 seconds with the HD Grid in a stable position and in contact with the atrial wall. These 30 seconds acquisitions are made in multiple, non-overlapping locations, so as to generate recordings over the entire atrial chamber. Once the data has been acquired, the data is anonymized and exported, via a portable external data storage device, to the laptop computer running the STAR Apollo Mapping System. The export data from the Ensite Precision or Ensite X EP systems consists of electrograms, electrode coordinates, ECG recordings and the geometry model. The data are imported, utilizing the portable external data storage device, into the STAR Apollo Mapping System and then processed by the STAR Apollo engine to generate a STAR Apollo map visualized by the GUI.