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.