Why Portable 6-Lead Devices Are the Future of Cardiac Monitoring in Clinical Trials
As crucial as QT determinations are in clinical trials for evaluating the safety of investigational drugs, the pain points surrounding them have become increasingly more difficult for sponsors, CROs, and patients to ignore.
The FDA emphasizes the importance of ECG evaluation early in development, stating:
"Drugs are expected to receive a clinical electrocardiographic evaluation beginning early in clinical development, typically including a single trial dedicated to evaluating their effect on cardiac repolarization ('thorough QT/QTc study')".
This regulatory perspective underscores the critical role of QT monitoring in ensuring drug safety.
The conventional reliance on 12-lead ECGs, while considered the gold standard for comprehensive cardiac monitoring, often necessitates on-site clinic visits. This imposes a logistical burden on patients and raises the risk of higher dropout rates and trial delays for sponsors. While indispensable for specific assessments, the routine use of these traditional methods can lead to unnecessary obstacles.
What if there was a way to supplement most trials with a solution that obtained all the essential cardiac data with far less burden?
This question is becoming increasingly relevant as the industry shifts towards more patient-centric trial designs, which drives broader adoption of digital health technologies. Significantly, portable 6-lead devices are not just a future promise; they are reshaping cardiac monitoring in clinical trials today with their clinical utility, flexibility, and patient-centric design.
Clinical Quality, 6-lead Device for QT Determinations
As an FDA-cleared and CE-marked, AI-enabled ECG technology, the 6-lead device significantly advances remote cardiac monitoring. This device enables clinical ECG data collection anytime, anywhere.
With AliveCor’s digital tools, patients can access, manage, and share their data independently, delivering the detailed insights needed for QT interval analysis. The 6-lead device allows for instant, automated cardiac rhythm determinations such as:
- Atrial fibrillation
- Bradycardia
- Tachycardia
- Sinus rhythm with SVE
- Sinus rhythm with PVCs
- Sinus rhythm with Wide QRS
The 6-lead device records medical-grade ECG to support QT interval monitoring, a required safety metric for many clinical trials, without requiring inconvenient and uncomfortable procedures.
As a trusted device for cardiac safety data by global pharma companies, the 6-lead device brings a new level of confidence and convenience for sponsors and CROs.
Efficient and Patient-Empowering
The shift towards patient-centered trial design is critical, as over 80% of clinical trials fail to reach recruitment targets. The 6-lead device serves as a transformative tool for clinical trials, enhancing participant recruitment and retention through its innovative user-friendly features:
- Operational Efficiency and Data Integrity. The most clinically validated personal ECG device, users can quickly record an ECG in just 30 seconds—leading to high patient adherence and ensuring consistent reliable data collection, essential for the integrity of trial outcomes.
- Reducing Participant Burden. By facilitating at-home ECG recordings, the 6-lead device enhances participant convenience and significantly reduces the logistical challenges and costs associated with in-person data collection.
- Patients are empowered like never before. Instead of getting poked and prodded by clinicians, users can actively participate in their care. This self-administration engages them and gives them control over their treatment and care, which is crucial for improving patient satisfaction and retention rates. Furthermore, the ability for quick self-administration at home opens the door to more diverse patient populations, improving trial results.
Trusted and Proven Critical to Cardiac Safety
The 6-lead device modernizes cardiac safety monitoring for clinical trials, addressing current challenges and paving the way for future innovations. Its integration into clinical protocols represents a significant leap towards more efficient, patient-friendly, and remote trial designs.
Ready to embrace the future of clinical trials? Discover how the 6-lead device can innovate your approach to cardiac safety monitoring.
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Blogs
JAMA Study Shows a 6-Lead Device Could Reduce the Need to Perform a 12-Lead ECG In Resource Limited Settings
At a QTc interval threshold of 500 milliseconds, the 6-lead device had a high negative predictive value of 99.8% and was an effective triage test. This validation is pivotal for sponsors aiming to deliver quality data while alleviating common cardiac monitoring challenges.
QT Monitoring Impacts More Than Just Cardiac Health
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?
Why Portable 6-Lead Devices Are the Future of Cardiac Monitoring in Clinical Trials
QT determinations are essential in clinical trials, but collecting them is challenging. Discover how the 6-lead device alleviates these challenges for more flexible and patient-centric trials.