Clinical Validation and Safety of the AC 12L ECG System Against a Standard of Care 12-Lead ECG (AC 12L ECG)

The purpose of this study is to collect clinical validation data to support an FDA submission for a 510(k) for the Kardia 12L hardware which enables the simultaneous diagnostic quality recording of all 6 limb leads and any chest lead. We will be recording both Leads V1 and V2 in a sequential fashion along with the V4 and Limb leads and a simultaneous 12-lead ECG to validate the hardware and a Deep Neural Network model which expands the 5 leads into a complete 12-lead ECG. The 12-lead ECG used for validation of the recordings and the 12-lead synthesis model is the GE Cardiosoft System which is FDA cleared.