5G Cloud-Enabled Telemedicine for Remote Management of Heart Failure Patients With Implantable Cardioverter-Defibrillators: A Multicenter Open-Label Randomized Controlled Trial.

Postoperative follow-up for patients with implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators (ICD/CRT-D) is often delayed in remote areas because of geographic barriers and limited healthcare resources, increasing the risk of adverse outcomes. The "Make Changes" study, was a prospective, multicenter, open-label randomized trial evaluating a 5G-cloud technology platform (5G-CTP) for real-time remote device interrogation and reprogramming versus standard In-clinic care. Between October 2022 and February 2024, 206 patients from five centers were randomly assigned to 12 months of follow-up with 5G-CTP (n = 104) or In-clinic care (n = 102). For the primary endpoint of time from clinical event to intervention, the 5G-CTP group had a significantly shorter response time than the In-Clinic group (4.2 vs. 11.5 days; p < 0.001). For secondary endpoints, the 5G-CTP group showed greater improvement in life quality at 12 months based on Minnesota Living with Heart Failure Questionnaire (p = 0.012). Rates of unplanned visits and clinical interventions were similar between groups, with no procedure-related complications. This model integrates community hospitals with implantation centers through 5G networks, enabling timely specialist-directed care locally without long-distance travel. It is a feasible strategy for postoperative ICD/CRT-D management, particularly in underserved regions with limited access to specialized cardiac care.