Turk Kardiyol Dern Ars. Ahead of Print: TKDA-39529 | DOI: 10.5543/tkda.2026.39529
Preliminary Validation of a Novel Low-Cost Arduino-Based Wireless Single-Lead ECG Device
Evrim Şimşek1, Mariano Ruffo2, Benay Özbay3, Burcu Yağmur1, Ahmet Can Urgancı1, Emre Ketenoğlu1, Gökçe Durmuş1, Hakan Gökalp Uzun4, Meral Kayıkçıoğlu11Department of Cardiology, Ege University Faculty of Medicine, İzmir, Türkiye
2Department of Electrical Engineering and Information Technology, University of Naples Federico II, Naples, Italy
3Department of Cardiology, Başakşehir Çam ve Sakura City Hospital, University of Health Sciences, İstanbul, Türkiye
4Department of Cardiology, İzmir City Hospital, İzmir, Türkiye
Objective: Although rhythm monitoring and opportunistic screening are becoming increasingly important in electrophysiology, access to electrocardiogram (ECG) devices remains limited in many resource-constrained regions. Our team developed a novel, easy-to-build, low-cost (<US$20), open-source, wireless single-lead ECG device using widely available components, including Arduino and Bluetooth. This preliminary study aimed to evaluate the recording capability and accuracy of the novel device by comparing it with a standard 12-lead ECG.
Method: Fifty healthy volunteers underwent standard 12-lead ECG recording and single-lead recordings using the novel device with four electrode configurations (P1–P4). Two cardiologists, blinded to the electrode configurations, graded the signal quality as good, acceptable, or unacceptable and measured the RR, PR, QRS, and QT intervals. Agreement between the novel device and the standard ECG was assessed using Bland–Altman analysis, while intraobserver and interobserver variability were evaluated using intraclass correlation coefficients (ICCs).
Results: The mean age of the participants was 36±8 years, and 50% were female. All participants were in sinus rhythm, which was successfully detected by the novel device in all electrode configurations. The PR, QRS, and QT intervals were measurable in all recordings. The proportions of recordings graded as having good signal quality were 88% for P1, 96% for P2, 84% for P3, and 84% for P4; no recording was rated as unacceptable. Bland–Altman analysis demonstrated good agreement with minimal bias, and the ICC values indicated excellent reproducibility (>0.90).
Conclusion: The novel low-cost, Arduino-based, wireless single-lead ECG device demonstrated high signal fidelity and strong agreement with the standard ECG for interval measurements in a controlled cohort of healthy volunteers.
Keywords: Arduino, Bluetooth, electrocardiography, mobile health, single-lead ECG, validation.
Corresponding Author: Evrim Şimşek
Manuscript Language: English