Comparative TQT analysis with three fully-automated platforms: comparison to core laboratory semi-automated results.

BACKGROUND AND PURPOSE

Technological advances in machine-read QT measurement now enable detailed and precise cardiac repolarization assessments. This study assessed the applicability of three state-of-art ECG measurement applications to provide reliable continuous analyses from data obtained in a positive thorough QT study previously characterized with sparse semi-automated measurements performed by an ECG core laboratory.

METHODS

Continuous RR, QT, QTc measurements, and individual QT/RR relationships and their associated intra- and inter-subject variability were derived in parallel with BioQT, Ponemah PRO, and WinAtrec analysis software.

RESULTS

Despite slight vendor-specific differences in measurement variability and QTc, all machine-read methods demonstrated requisite assay sensitivity and yielded similar conclusions in accordance with SA analysis.

CONCLUSIONS

Three commercially available ECG analytical software applications reliably detected the drug-induced QT prolonging effects and replicated the SA core-laboratory conclusions, with greatly improved temporal resolution and reduced analytical costs. With broader experience, these data suggest that current SA methodologies could be effectively replaced by fully automated ECG analysis.