Development and Clinical Evaluation of a Wearable 12-Lead Electrocardiographic Platform with Automated ECG Analysis for Telemedicine Applications

Vollständiger Abstract

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Wearable electrocardiographic technologies have become increasingly important for continuous cardiac monitoring; however, most existing portable systems are limited by the number of recorded leads or provide only basic signal acquisition without advanced automated analysis. This study presents a third-generation wearable twelve-lead electrocardiographic platform developed for multilead ECG acquisition and automated spatial ECG analysis. Compared with the previous generation, the hardware modification primarily consists of architectural consolidation: functions previously distributed across an STM32 microcontroller and separate wireless communication modules are integrated into a single ESP32-S3-based architecture, while the ECG acquisition principle, ten-electrode configuration, and sampling rate remain unchanged. The main methodological contribution of the present work is the software pipeline for lead-specific ST80 measurement and analysis of ST-segment deviations across anatomically contiguous leads. The system uses an ADS1298 analog front-end for synchronized multichannel ECG acquisition. The host software performs digital preprocessing, R-peak detection, ECG feature extraction, twelve-lead reconstruction, lead-specific ST80 measurement, contiguous-lead analysis, and generation of a preliminary computer-assisted ECG report. The developed platform was clinically evaluated using sequential recordings acquired with the proposed system and a reference clinical electrocardiograph. Quantitative comparison of automated PR, QRS, QT, and QTc measurements in 30 paired recordings demonstrated positive correlations with the reference BTL Flexi 12 ECG (r = 0.756–0.820, all p < 0.001), with mean absolute errors ranging from 2.53 ms for QRS duration to 10.40 ms for the QT interval. The system successfully recorded diagnostically interpretable twelve-lead ECGs in all participants and produced stable signal quality suitable for clinical assessment. The software automatically identified ECG waves and intervals, reconstructed twelve-lead recordings, evaluated ST-segment deviations across individual leads, and localized ischemia-related changes according to standard anatomical lead groups. Integration of signal acquisition, processing, visualization, and automated interpretation into a single telemedicine-oriented platform reduced hardware complexity while maintaining reliable multichannel ECG monitoring. The proposed wearable platform demonstrates the feasibility of combining compact embedded hardware with automated multilead ECG analysis for remote cardiovascular monitoring. The presented architecture provides a practical foundation for telemedicine applications and may support earlier recognition of clinically significant electrocardiographic abnormalities during ambulatory monitoring.