![]() ![]() All reports were received by the clinic and processed per standard operating procedure. Readers in both IDTFs were unaware of patients’ clinical trial enrollment status to ensure that readings were routine and not enhanced. Monitors were returned for processing per standard clinic guidelines and reports were prepared by each IDTF. Only periods of concomitant wear of both devices were examined for purposes of this study. ![]() Patients were instructed to remove each monitor at the end of the prescribed wear time at day 30 for the MCT devices and at day 14 for the LT-ECG, or as tolerated by the patient. 1.1.3 for patients 42–50 Bardy Diagnostics). The LT-ECG monitor used a Medicare-approved independent data testing facility (IDTF) that used arrhythmia-trained human review of the entire recording period before and after a pass with Monarch TM visualization software that is designed to facilitate human analysis (v. The second form of ECG monitoring technology was continuous LT-ECG monitoring, sometimes called long-term “Holter,” and was restricted to the Carnation Ambulatory Monitor (Bardy Diagnostics), our only LT-ECG used. There is no such review during CEM unless specifically requested by the patient. The predominant difference between MCT and CEM is merely the 24/7 availability of a human to review algorithmic-identified events and to phone the clinic for arrhythmias that are considered critical, hence the increased cost. Moreover, it is the same regardless of whether MCT defaults to CEM or not. That said, the algorithmic diagnostic process is the same. Three different models of MCT were used from the same manufacturer, but all 3 have the same endpoint methodology employed with various electrode configurations. ![]()
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