An interventional study of AI-ECG driven ECG monitoring in Artificial Intelligence (AI), Cardiac Implantable Electrical Devices and Conduction Disorder of the Heart, sponsored by National Defense Medical Center, Taiwan. Recruiting at 1 site in Taiwan. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by National Defense Medical Center, Taiwan · Not applicable, Interventional, and Screening
The goal of this clinical trial is to learn whether an artificial intelligence-enhanced electrocardiogram (AI-ECG) strategy improves timely intervention of patients requiring cardiac implantable electronic devices (CIEDs), compared with standard clinical care.
This is a randomized controlled trial designed to evaluate the impact of an AI-ECG strategy on the identification of patients requiring CIEDs. The ECGs of eligible participants will be analyzed by a previously validated deep learning algorithm. Those classified as high-risk by the AI-ECG system will be allocated at random into either the intervention group or the control group.
In the intervention group, the physicians will be alerted by the AI-ECG system, and the participants will be proactively contacted to receive ambulatory continuous ECG monitoring for up to 7 days. In the control group, the participants will continue with usual clinical care, and treating physicians will not have access to the AI-ECG results before the end of this study. To ensure accuracy, the reference standards for device indications will be performed by a panel of experienced cardiologists without access to the AI-generated reports.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's planned enrollment of 11,492 is above the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →National Defense Medical Center, Taiwan is the lead sponsor of 63 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Diagnostic Test: AI-ECG driven ECG monitoring
Participants identified as high-risk for CIED implantation by the AI-ECG system will receive a continuous cardiac rhythm monitor for up to 7 days.
CIED implantation
The number of participants who undergo CIED implantation within the study period. The CIEDs include conventional transvenous pacemakers, leadless pacemakers, and implantable cardioverter-defibrillators (encompassing transvenous, subcutaneous, and extravascular systems).
Time frame: Within 180 days after randomization
Number of High-Grade Atrioventricular Block
Time frame: Within 90 days after randomization
Number of Complete Atrioventricular Block
Time frame: Within 90 days after randomization
Number of Sick Sinus Syndrome
Time frame: Within 90 days after randomization
Number of Ventricular Arrhythmia
Time frame: Within 90 days after randomization
Adverse Events Related to Continuous ECG Monitoring
The number of adverse events associated with continuous ECG monitoring, including mild to moderate skin irritation, contact dermatitis, or discomfort at the site of patch application, as well as other procedure-related minor complications arising from extended ECG monitoring.
Time frame: Within 90 days after randomization.
Number of CIED-Related Complications
Time frame: Within 90 days after randomization.
Plan to share: No
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National Defense Medical Center, Taiwan