AliveCor shared today that M-KEEPS—a new prospective cohort study conducted by researchers at the University of Rochester Clinical Cardiovascular Research Center (Rochester, USA)—has been published in JACC: Advances. The study establishes that 30-day use of the handheld KardiaMobile 6L (KM6L) device outperforms traditional short-duration ambulatory electrocardiogram (ECG) monitoring alone in detecting clinically significant arrhythmias, as stated by AliveCor in a press release.
The company also notes that its KM6L device achieved an overall diagnostic yield of nearly double compared to standard clinical monitoring modalities.
The study evaluated 350 adult patients presenting with unexplained palpitations, dizziness or lightheadedness who were concurrently tracked using both a physician-ordered standard ambulatory monitor—24/48-hour Holter or an extended patch ECG monitor—and a KM6L device for 30 days.
Clinically significant arrhythmias were detected in 66 patients (18.9%) overall across both monitoring types. Traditional ambulatory monitors identified arrhythmias in only 27 patients (7.7%), whereas the KM6L device detected arrhythmias in 52 patients (14.9%; p<0.001). A total of 39 arrhythmia episodes (11.1%) were captured exclusively by the KM6L device and completely missed by conventional continuous monitoring options (p=0.0008), AliveCor also claims.
Additionally, in an exploratory analysis of patients wearing extended patch ECG monitors for seven days or longer, the patch devices documented arrhythmias in nine out of 93 patients (9.8%) while the KM6L device detected arrhythmias in 22 out of 93 of those same patients (23.9%; p<0.0001). AliveCor notes that the most common arrhythmia missed by traditional monitoring but detected by the KM6L device was atrial fibrillation (AF).
“The M-KEEPS study showed that the KardiaMobile 6L handheld device enabled patient-initiated ECG recordings with 88% of participants—across a broad range of ages and with two-thirds being women—evaluating the device as easy to use,” said Wojciech Zareba (University of Rochester, Rochester, USA). “Symptom-triggered ECG recordings obtained over 30 days were superior to standard 24- or 48-hour Holter recordings and to prolonged multiday recordings in detecting clinically significant arrhythmias. KM6L might be considered as the first line of diagnostic process in individuals with uncertain causes of cardiac symptoms.”
The research team also highlighted how real-world clinical paradigms are shifting toward patient-activated technology to address these exact workflow bottlenecks.
“Traditional short-duration monitoring simply misses too many transient events, creating a costly diagnostic blind spot for clinicians,” added Dave Albert, chief medical officer and co-founder of AliveCor. “This landmark study from the University of Rochester proves that putting our medical-grade, six-lead device directly into patients’ hands nearly doubles the diagnostic yield. By empowering patients to capture arrhythmias the moment symptoms occur, we can accelerate accurate diagnoses, optimise clinical workflows, and get patients to lifesaving treatment faster—ultimately preventing critical cardiac episodes and the compounding costs of undetected conditions.”
According to AliveCor, a critical element of deploying consumer-facing medical technology is patient adherence and signal reliability. Across 6,251 total KM6L recordings collected during the study, 92.3% of the total recordings were deemed clinically interpretable by research technicians. In direct head-to-head temporal alignments, 88.3% of KM6L recordings were classified as top-tier, readable ECGs compared to 86.7% of traditional Holter recordings.
Patient survey results at the end of the 30-day testing period indicated significant compliance and clinical satisfaction across a diverse demographic, where two-thirds of study participants were female. Some 88% of surveyed participants strongly agreed that the KM6L smartphone application was easy to use, 70% strongly agreed that obtaining a six-lead ECG recording utilising the left leg electrode was easy to complete, and 88% strongly agreed that they felt more confident using the device to actively document their heart rhythms.
AliveCor concludes by stating that, in practice, the KM6L device functions seamlessly as an adjunct early in the cardiac diagnostic pathway. By reducing repeated short-term monitoring loops, the technology is intended to speed up symptom-rhythm correlation, easing patient anxiety and minimising unnecessary healthcare expenditures associated with an extended diagnostic search.
