Study Endpoints
The aim of the study was to evaluate the efficacy and patient satisfaction with the new CESC protocol adopted during COVID-19 lockdown.
The primary endpoints were: 1) “RM Activation Time” in Group hdRM vs Group odRM , defined as the time to first independent manual transmission since modem was delivered; 2) Need for technical support inGroup hdRM vs Group odRM, defined as the number of phone calls or IPEs the patient required due to technical problems activating the RM system.
The secondary endpoints were: 1) Number and type of clinically relevant RM transmissions in the overall RM population, including CIED alerts (battery depletion time, abnormal threshold, sensing and impedance measurements), arrhythmic events (atrial fibrillation (AF), supraventricular tachycardia (SVT), ventricular tachycardia (VT) and bradycardia), ICD therapies, HF-related alerts. 2) Number of emergent/urgent IPEs and hospitalizations; 3) Patient’s acceptance and anxiety status with the new workflow.