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

ABSTRACT 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.