A new peer-reviewed study published in JAMA determined that the KardiaMobile® 6L is highly accurate compared to a traditional 12-lead ECG in detecting drug-induced QT prolongation due to tuberculosis treatment.
With proven 99.8% accuracy, the remote-friendly, easy-to-use, handheld device is pivotal in delivering high-quality trial data while alleviating long-standing cardiac monitoring challenges.
While long trusted as the gold standard for cardiac monitoring, traditional 12L ECGs require a consistent power supply, specialized equipment, and trained personnel to accurately place leads, making them less practical and cost-effective, especially in resource-limited settings.
Additionally, the in-person office visits required for 12-lead ECGs can be invasive and burdensome for patients, leading to decreased adherence and the potential for decreased recruitment and study progress.²
The KardiaMobile 6L can reduce study costs and resource usage by eliminating the need for expensive, time-consuming, and non-portable 12L ECG machines. In settings where remote monitoring is vital but traditionally burdensome, like patient homes or resource-limited sites, KardiaMobile 6L offers efficient and non-invasive cardiac monitoring. This ease of use allows for broader demographic and geographic participation in clinical trials, ensuring diverse populations are included in research.
The handheld, user-friendly design of the KardiaMobile® 6L reduces the burden on patients while empowering them to take control of their care. Able to complete an ECG in 30 seconds without wiring or patches, patients can avoid the time-consuming procedures associated with 12L ECGs. This streamlined approach enables sponsors to better recruit and retain participants while ensuring high-quality data collection and compliance.
In any clinical setting, the portable KardiaMobile 6L provides high-quality results faster and more easily, streamlining clinician workflow. The ability to transmit data in real time allows sponsors to receive ECG data from any location, speeding up the trial process and maximizing efficiency.
A recent study conducted in South Africa and published by JAMA (“Validation of a Handheld 6-Lead Device for QT Interval Monitoring in Resource-Limited Settings”) compared the KardiaMobile® 6L to traditional 12L ECGs in a resource-limited setting. The 6L device delivered data with near-perfect accuracy.
“At a QTc interval threshold of 500 milliseconds, the handheld 6-lead device had a high negative predictive value of 99.8%¹”
The results not only showed that the 6L delivered data with astoundingly equal effectiveness, but it also found that it was far more preferred by clinicians. Citing the need for specialized supplies, consistent power, and trained personnel to accurately place leads, clinic professionals noted the 12L device was more difficult to use.
75% of nurses in the study reported a significant preference for the KardiaMobile® 6L over traditional 12L devices. 100% said they were confident in the results.³
“Most nurses (75%) reported that the 6-lead device was easy to use and that patients were more satisfied with the testing relative to the 12-lead ECG, all were confident in the results provided and felt that the 6-lead device would improve clinic workflow, and most (75%) recommended the 6-lead over conventional 12-lead device.”
The proven efficacy of remote cardiac monitoring technology signifies a shift towards innovative, efficient, and patient-friendly clinical trials. This breakthrough challenges the traditional 12-lead ECGs and paves the way for adaptable and scalable approaches in clinical trials and routine care.
Adopting digital health technologies is expected to enhance the speed and quality of clinical research by reducing logistical constraints and improving data accuracy. This supports the demand for decentralized and hybrid clinical trials, integrating real-world data seamlessly.
Moreover, embracing such technologies highlights the industry’s commitment to innovation and patient-centricity, ensuring accessibility and inclusivity in medical research. The integration of these devices will drive further advancements in digital health, contributing to a more connected and responsive clinical research ecosystem.
Read the full article to discover how advanced ECG technologies can transform your clinical trials.
1,2 Chang, Ruey-Kang. “12-Lead ECG Systems in Clinical Trials.” Clinical Trials Arena. 23 November 2018. clinicaltrialsarena.com.
3 Metcalfe JZ, Economou T, Naufal F, et al. Validation of a Handheld 6-Lead Device for QT Interval Monitoring in Resource-Limited Settings. JAMA Netw Open. 2024
Beyond its traditional focus on cardiac-specific therapies, every investigational drug can potentially impact cardiac function. What if we expanded QT monitoring across various therapeutic areas?
Wiley.com | Clinic utilization time is significantly reduced with the KardiaMobile® 6L compared to traditional 12L ECG systems. This study published in Wiley highlights how the 6L minimizes the need for frequent conventional 12L use.
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.