EPIC-RM: Evaluating the clinical safety and cost-effectiveness of Exception-based Patient care Cardiac Implantable Electronic Devices (CIED) Remote Monitoring

This is a phase 3, multi-centre, open-label, prospective, parallel arm, randomised controlled trial in CIED patients. These patients with CIEDs include those with permanent pacemakers (PPMs) and implantable cardioverter defibrillators (ICDs). We will compare remote monitoring of CIEDs in conjunction with standard care, versus standard care alone. In addition to the required study arm, we will evaluate an Exception-Based Care Remote Monitoring (EBC-RM) model for CIED patients over 4 years. We will include the composite of safety events to assess the relative clinical safety and cost impact of each of the comparator strategies, with participants followed up for a minimum of 24 months. Three arms of the trial: a) Exception-based care remote monitoring: Participants allocated to EBC- based RM will receive an in-office check at weeks 1- 6 to check wound healing in the case of PPM or ICD implants according to local procedures and establish remote monitoring (participants with recent CIEDs only). Participants would undergo remote monitoring using the standard profile of their specific device, with scheduled transmissions at 6-monthly intervals. Participants would receive communication from the remote monitoring team (i.e. consultant, cardiologist, electrophysiology fellow, cardiology advanced trainee, nurse or allied health practitioner involved in CIED care), at their local institution via text message or letter, 6-monthly. Participants in this arm would undergo any routine care from their cardiologist as they would require for any prior cardiac conditions, but not have a scheduled device check as part of this care. If participants experienced device-detected adverse findings related to CIED function or health status change (e.g., detection of AF via remote monitoring), participants would be called into clinic for appropriate clinical management. For participants already followed up by a cardiologist, written advice updating their treating cardiologist with recommendations for changes to clinical management would be provided. CIED technology allow interrogation and transmissions of data stored in these devices wirelessly i.e., device function, cardiovascular events, and patient clinical status. All data is continuously saved within the device memory. During device interrogation, telemetry is used to retrieve information on the CIED programmed parameters and data stored in the CIED memory. During remote monitoring, a device designed to receive telemetry from a specific CIED will transmit encrypted data using telephone technology to a remote-secure monitoring centre/server (i.e., your local hospital or clinic). Often the home monitor or communicator is stationary and connected to the internet through an analogue telephone line in the patient’s home, but it can also be a portable unit. b) Remote monitoring plus scheduled in-office follow-up: Participants allocated to remote monitoring plus scheduled in-office follow-up would be managed as above but would also have a scheduled 6-monthly office follow-up (in the case of ICDs), or 12-monthly follow-up (in the case of PPMs). The scheduled in-office follow-up would be performed as per local protocols, by cardiologists, cardiac physiologists or CIED care nurses. Participants in this group would remain eligible to be called for unscheduled clinic appointments as required to deal with device-detected adverse findings, related to CIED function or health status change, as above. All participants, across all three arms (including comparator arm) will be followed up according to local clinical protocols should they experience unscheduled device related changes to their health status as part of study outcomes. Furthermore, adherence to trial will be monitored by communication from the study team. The study team will communicate upcoming remote monitoring, and/or office-based check up dates and requirements (i.e. questionnaire completion) with participants at appropriate intervals.