Abstract
Introduction: There is an increasing clinical interest using wearable single-lead ECG sensors for continuous cardiac monitoring. Hypothesis: However, there is limited to qualify the reliability of those. The purpose of this study is to assess ECG signal quality assessments of real-time wearable SmartPatch (HiCardi Plus) compared to 12-lead ECG. Methods: To analyze the similarity between the standard 12-Lead ECG and HiCardi Plus signals, 31 subjects were simultaneously acquired with SmartPatch (HiCardi Plus) and 12-Lead ECG. The 12-lead ECG equipment used in this experiment is IntelliVue Patient Monitor MX700 (Philips) Results: It was found that even if the distance between electrodes was short, the ECG signal measured from the electrode pair located diagonal (direction of the electrical axis of the heart) and vertical direction with chest had a very high correlation with the standard 12-lead ECG signal and was sufficient for diagnosis Conclusions: Our device (HiCardi Plus) has substantial equivalence with standard 12-Lead ECG, in terms of QRS-complex detection and arrhythmia classification in the intended use condition.
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