VivaLNK’s wireless device can now be used to capture changes in heart rate and electrical activity in people with pulmonary hypertension (PH) or other disorders during the six-minute walk test (6MWT), a routine exercise endurance test.
This wearable electrocardiography (ECG) monitor allows for in-clinic and remote patient monitoring, meaning that it may potentially lower the need for hospital visits, reducing the burden of disease monitoring for both patients and physicians.
“Medical wearables are making it possible to explore new, potentially meaningful outcomes in clinical studies without adding much additional burden to patients or their clinicians,” Robert F. Roscigno, PhD, vice president of clinical development at Gossamer Bio, said in a press release.
The 6MWT, which typically measures the distance one can walk in six minutes, is often used to assess the functional capacity or endurance of patients with chronic diseases, including PH, chronic obstructive pulmonary disease, and congestive heart failure.
However, this endurance test cannot, by itself, be used to assess the impact that the physical strain may have on patients’ heart and lung function. Now, by creating an ECG monitoring device that can be easily worn during the 6MWT, VivaLNK is providing patients and physicians with a convenient, integrated monitoring system that can record changes in heart rate and electrical activity during exercise.
The device comprises a wireless patch that is attached to the skin. Once placed, the patch can continuously record respiratory and heart rates, as well as several parameters of heart function and electrical activity.
Compared to wire-based monitoring devices, VivaLNK’s wireless ECG monitor is more comfortable, as it is small, lightweight — it weighs 7.5 grams — and discreet when used. It is also reusable, rechargeable, and water-resistant.
The device also includes a mobile app that allows clinicians to manage some parameters during the test. Then, data is merged into an integrated database in a cloud system so it can ultimately be analyzed.
Several studies in multiple health research fields have used the device. One of these studies, known as the Hypertension Drug Trial, is using it to assess the heart rate and electrical activity of up to 80 participants across multiple locations before, during, and after completing the 6MWT.
The study showed that the device was able to tackle and overcome several key issues. One of them was the ability to consolidate data from multiple sites. Another one was the capacity to use a customized app protocol that facilitated data collection, even when sporadic network interruptions occurred. Moreover, the device’s built-in algorithms allowed for it to record different heart function parameters without being disturbed by motion artifacts.
In addition, the company’s wearable devices and data platforms are being used for other purposes, including mobile cardiac telemetry (a way to monitor a person’s vital signs remotely), detection of events related to cancer treatments or heart failure, and cardiac rehabilitation.
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