Analyzing the delineation precision of Hannover ECG System (HES®): A validation study

There is a large interest in analyzing QT/QTc measurements (e.g. in clinical studies during drug safety evaluations), since prolonged QT intervals can cause ventricular tachyarrhythmias or other critical cardiac rhythm events. Furthermore a set of guidelines for clinical evaluation of the QT/QTc interval prolongation (for instance E14) is provided by the ICH. Due to the significance of the QT measurement for drug safety, the objective of this work is to compare the results of manual annotated QT and RR interval measurements with the results of the fully-automated HES^® algorithm for validation purposes in clinical studies. In order to enhance the validity of the statistical test and to exclude adaptation between test data and algorithm, the number of test cases is set to more than 42000 annotated ECG signals. The statistical differences between QT and RR interval was observed to demonstrate the ability and reliability of automated methods using the HES^® algorithm.