Abstract：Objective To evaluate the safety and efficacy of a single-lead electrocardiograph recorder(Rhythm WatchTM) in guiding the detection of atrial fibrillation(AF). Methods All subjects were simultaneously detected by the test device and 12-lead electrocardiograph. Data from the test device and 12-lead electrocardiogram reports were separately diagnosed by the data analysis committee.Given the diagnostic results of 12-lead electrocardiogram as a gold standard, the accuracy rate of test product in AF detection was calculated. Results In the guidance of single-lead electrocardiograph recorder, 100% of AF can be screened out. During the whole test process, no adverse event associated with the test equipment happened. ConclusionIn our study, the single-lead electrocardiograph recorder proves to be safe and effective in clinical practice. It is equivalent to 12-lead electrocardiograph in the accuracy of AF detection.
2018, Vol. 27 
