Patients in clinical studies are set to use AliveCor’s Kardia Mobile device to accurately record medical-grade ECGs anytime, in any location, in just 30 seconds
27 June 2016: Exco InTouch, the leading provider of patient engagement and data capture solutions for clinical research and healthcare providers, has today announced a partnership with AliveCor, the leader and pioneer in machine learning techniques and mobile electrocardiogram (ECG) technology for proactive heart care, in order to make mobile ECG measurements available in clinical study research. AliveCor has secured global recognition for transforming cardiac care and its Kardia platform is recommended for use by prominent cardiologists and is currently being utilised internationally.
As part of its commitment to driving industry innovation, Exco InTouch is set to bring the benefits of AliveCor’s FDA 510(k) and EU Class II approved Kardia Mobile device to the clinical research community. The device is the most clinically validated mobile ECG system available, and is already firmly established in worldwide consumer markets, enabling people to take an active role in their heart’s health by taking accurate ECG recordings. Over 7 million ECGs have been recorded to date, with the number growing by approximately 20,000 a day. As a consequence of the partnership, the ability to capture ECG information during clinical studies is now made possible.
Kardia Mobile indicates to patients if their heart rhythm is normal or if atrial fibrillation (AF) is detected. The technology delivers highly accurate results, and makes it easy for patients to share ECG data with their doctors for accurate analysis and diagnosis. The user-friendly design and easy accessibility provides a strong advantage to patients over traditional monitoring solutions. This enables patients to record medical-grade ECGs anytime, in any location, including in a patient’s own home, in just 30 seconds flat.
The technology, which takes the form of a fully portable and unobtrusive device that links seamlessly into mobile data capture generates validated information on a patient’s heart rate and rhythm. This enables a patient’s ECG to be collected more frequently at patient elicited time points (i.e. when they feel unwell) and/or at planned time points throughout the clinical trial. This directly addresses the fact that changes and fluctuations in heart rhythm can occur at any point – not just during clinic visits. Consequently, the partnership is set to have a transformational impact on ECG capture in clinical studies.
Kardia Mobile is comparable to Lead 1 of standard ECG machines. Moreover, researchers at the Leeds General Infirmary, UK, found the device is superior to conventional Holter monitoring in patients with palpitations, providing a higher diagnostic yield, more detected arrhythmias, with a similar workload.
Dr. David Albert, founder and Chief Medical Officer of AliveCor, commented: “We welcome the opportunity to work together with Exco InTouch to bring our patient-friendly, medical grade technology to improve the way cardiac monitoring is conducted in clinical research.”
Tim Davis, CEO and founder of Exco InTouch commented: “We are very excited about this partnership. Indeed, we are always looking to utilise proven consumer grade technology and to bring it into the realm of clinical research. AliveCor’s Kardia Mobile is a terrific example of how technology can extend the boundaries of endpoint data collection in clinical research to the benefit of patients.”
He continued: “I feel too that the transformational impact of the use of this technology is especially significant – as, where appropriate, we are taking ECG out of the doctor’s surgery and putting it into the hands of the patient to enhance the breadth of data that can be captured as part of patient reported outcomes.”
Exco InTouch will be showcasing Kardia Mobile at DIA 2016. Visit booth 624 for a demonstration.