Key result
AliveCor KardiaMobile 6L matches standard 12-lead ECG QTcF measurements with a ~3 ms difference.
Why the study?
The study evaluated interval duration measurements between standard 12-lead ECGs and 6-lead ECGs recorded with a hand-held mobile device designed for home use.
Does a 6-lead mobile ECG device provide comparable interval duration measurements to a standard 12-lead ECG in patients evaluated at a genetic heart rhythm clinic?
Observational (n=705)
Single-blind
No
Does a 6-lead mobile ECG device provide comparable interval duration measurements to a standard 12-lead ECG in patients evaluated at a genetic heart rhythm clinic?
Effect estimate: Mean difference -2.6 ms (95% CI -4.1 to -1.1)
Absolute Event Rate: 428.5% vs 431%
A 6-lead mobile ECG device provides interval duration measurements comparable to a standard 12-lead ECG, supporting its utility for remote patient monitoring and clinical trial safety follow-ups.
BACKGROUND: Interval duration measurements (IDMs) were compared between standard 12-lead electrocardiograms (ECGs) and 6-lead ECGs recorded with AliveCor's KardiaMobile 6L, a hand-held mobile device designed for use by patients at home. METHODS: Electrocardiograms were recorded within, on average, 15 min from 705 patients in Mayo Clinic's Windland Smith Rice Genetic Heart Rhythm Clinic. Interpretable 12-lead and 6-lead recordings were available for 685 out of 705 (97%) eligible patients. The most common diagnosis was congenital long QT syndrome (LQTS, 343/685 [50%]), followed by unaffected relatives and patients (146/685 [21%]), and patients with other genetic heart diseases, including hypertrophic cardiomyopathy (36 [5.2%]), arrhythmogenic cardiomyopathy (23 [3.4%]), and idiopathic ventricular fibrillation (14 [2.0%]). IDMs were performed by a central ECG laboratory using lead II with a semi-automated technique. RESULTS: Despite differences in patient position (supine for 12-lead ECGs and sitting for 6-lead ECGs), mean IDMs were comparable, with mean values for the 12-lead and 6-lead ECGs for QTcF, heart rate, PR, and QRS differing by 2.6 ms, -5.5 beats per minute, 1.0 and 1.2 ms, respectively. Despite a modest difference in heart rate, intervals were close enough to allow a detection of clinically meaningful abnormalities. CONCLUSIONS: The 6-lead hand-held device is potentially useful for a clinical follow-up of remote patients, and for a safety follow-up of patients participating in clinical trials who cannot visit the investigational site. This technology may extend the use of 12-lead ECG recordings during the current COVID-19 pandemic as remote patient monitoring becomes more common in virtual or hybrid-design clinical studies.
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Kleiman et al. (2021) conducted an observational in Genetic heart diseases (primarily long QT syndrome) (n=705). AliveCor KardiaMobile 6L vs. Standard 12-lead ECG was evaluated on Mean difference in QTcF (Mean difference -2.6 ms, 95% CI -4.1 to -1.1). The AliveCor KardiaMobile 6L device produced interval duration measurements comparable to a standard 12-lead ECG, with a mean difference in QTcF of -2.6 ms.
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