Key result
5G-cloud remote monitoring cuts time to clinical intervention by ~7 days vs. in-clinic care.
Why the study?
Postoperative follow-up for patients with ICD/CRT-D is often delayed in remote areas due to geographic barriers and limited healthcare resources, increasing adverse outcome risk.
Does a 5G-cloud technology platform for remote management reduce the time to clinical intervention compared to standard in-clinic care in heart failure patients with ICDs or CRT-Ds?
RCT (n=206)
Open-label
1:1 permuted block randomization, stratified by center
Yes
Does a 5G-cloud technology platform for remote management reduce the time to clinical intervention compared to standard in-clinic care in heart failure patients with ICDs or CRT-Ds?
Mean Difference: -7.3 (95% CI -8.9–-5.7)
Absolute Event Rate: 4.2% vs 11.5%
p-value: p=<0.001
A 5G-cloud technology platform enabling remote device interrogation and reprogramming safely and significantly reduces the time to clinical intervention for ICD/CRT-D events in heart failure patients.
Enables faster remote interventions for HF patients with ICDs/CRT-Ds; extends evidence for 5G telemedicine in device management.
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.
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Li et al. (2026) conducted an RCT in Heart failure with newly implanted ICD or CRT-D (n=206). 5G-cloud technology platform (5G-CTP) vs. Standard In-clinic care was evaluated on Time from clinical event occurrence to initiation of clinical intervention (MD -7.3 days, 95% CI -8.9 to -5.7, p=<0.001). The 5G-cloud technology platform significantly reduced the mean time from clinical event detection to intervention by 7.3 days compared to standard in-clinic care.
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