Handheld 6-Lead Validated for QT Monitoring
In this diagnostic study, a standard 12-lead ECG measurement was compared to a 6-lead device in a tuberculosis trial. Performed in South Africa, the study assessed 191 participants. Triplicate reference standard 12-lead ECG results were human calibrated with readers blinded to 6-lead ECG results.
At a QTc interval threshold of 500 milliseconds, the 6-lead device had a high negative predictive value of 99.8%.
This study suggests that simplified, handheld 6-lead ECG devices are effective triage tests that could reduce the need to perform standard 12-lead ECG monitoring in resource-constrained settings.
Key Takeaways:
- At a diagnostic cut point of 500 milliseconds, 98.8% of clinic visits (483 of 489) were correctly classified by the handheld 6-lead device:
- 482 as true negatives (ie, QTc interval <500 milliseconds measured by both devices)
- 1 as true positive (ie, QTc interval of ≥500 milliseconds measured by both devices)
- In resource-limited settings where QT screening is needed, the 6-lead device can be a cost-effective (20-50 times less costly than the conventional ECG), efficient, and reliable triage tool, resulting in more patient-centered care
- There is proven diagnostic accuracy, repeatability, and feasibility with the 6-lead device
Clinical Evidence
Handheld 6-Lead Validated for QT Monitoring
JAMAnetwork.com | A 6-lead device transforms cardiac care in resource-limited settings. This study in JAMA highlights its accuracy in monitoring QT intervals, reducing standard 12-lead ECG dependency, and easing access to cardiac care.
Remote Monitoring in Decentralized Trials
JAMAnetwork.com | Patient-centric trials require accessible digital health technologies. A JAMA study explores the current state and aspired role of remote monitoring and data collection tools in oncology trials.
KardiaMobile® 6L vs 12-lead ECG Impact on Clinic Time
Wiley.com | Clinic utilization time is significantly reduced with the KardiaMobile® 6L compared to traditional 12-lead ECG systems. This study published in Wiley highlights how KardiaMobile 6L minimizes the need for frequent conventional 12-lead use.