A Wearable ECG Device for Differentiating Hypertrophic Cardiomyopathy from Acquired Left Ventricular Hypertrophy

Hypertrophic Cardiomyopathy (HCM) is a genetic heart disease affecting approximately 1 in 500 people and is the leading cause of sudden cardiac death in young athletes. Current diagnostic methods – cardiovascular magnetic resonance (CMR), echocardiography, and genetic testing – are limited by high costs, operator dependency, or insufficient accuracy, while standard electrocardiogram (ECG) analysis cannot reliably distinguish HCM from acquired left ventricular hypertrophy (LVH). This paper presents a wearable ECG device paired with a classification algorithm that differentiates HCM from acquired LVH using ECG signals alone. The portable device integrates a 3-lead electrode system, an AD8232 signal conditioning module, an Arduino Nano 33 BLE microcontroller, and a lithium polymer battery. The algorithm extracts two quantitative indices – HCM Index~1 and HCM Index~2 – from each heartbeat and classifies patients via dual statistical thresholds. Validation on 483 LVH patients (PhysioNet) and 29 HCM patients (digitized clinical records) yields 75.86% sensitivity, 99.17% specificity, and an F1-score of 80.00%. Leave-one-out cross-validation confirms generalizability, with cross-validated sensitivity of 72.41%, specificity of 98.96%, and F1-score of 76.36% (95% confidence intervals reported). A digitization confound analysis demonstrates that the classification is driven by physiological cardiac features rather than data source artifacts. A simulated device acquisition chain analysis confirms that the wearable hardware’s signal characteristics are compatible with the classification algorithm. The system offers a promising tool for affordable HCM screening in resource-limited settings.