ATsens’s Himalayan arrhythmia risk study using AT-Patch published in JAMA Cardiology

2024-05-28     Korea Biomedical Review

ATsens, a leading provider of bio-signal-based healthcare platforms, said Tuesday that the results of the world's first clinical study of arrhythmias in Mt. Everest climbers using its patchable long-term continuous electrocardiogram (ECG) device, AT-Patch, have been published in the May issue of JAMA Cardiology (IF 24.0).

The study, "Risk of Cardiac Arrhythmias among Climbers on Mount Everest," examined the risk of arrhythmias using the ATP-C130E during extreme altitude climbing on Mt. Everest, which reaches 8,849 meters above sea level.

AT-Patch was used in the study on Everest climbers. (Courtesy of ATsens)

The researchers placed the ATP-C130E on 34 healthy climbers who reached the base camp at 5,300 meters above sea level and measured their ECGs during the climb to the summit. The data was analyzed using AT-Report, an ECG analysis program with artificial intelligence (AI) algorithms. The results showed that 13 of the 34 climbers (38.2 percent) had arrhythmias, such as bradyarrhythmia and ventricular tachycardia, confirming the association of arrhythmias with high altitudes.

The study's device detected 45 arrhythmias, even in extreme altitude and low-pressure environments. None of the arrhythmias identified were accompanied by symptoms. After preliminary clinical testing, the researchers selected the device to find a patchable ECG that could record normal electrocardiograms without falling off during strenuous climbing. The device was also rated as comfortable to use while climbing.

In a field note published on the Swiss Polar Institute's website, Professor Thomas Pilgrim of the University of Bern, Switzerland, who participated in the study, said that during a small pilot study before the clinical trial, he forgot to wear the patch while climbing.

The AT-Patch is Korea's first long-term continuous ECG device to receive U.S. FDA approval and European CE medical device certification.

Despite its ultra-compact, ultra-lightweight appearance of 8.3mm thick and 13g in weight, it is equipped with technology that can continuously measure ECG for 14 days without changing or charging batteries. The proprietary sensor chip, a short electrode integrated with the patch, minimizes noise, sensitively detects ECG signals, and captures the waveform. Long-term ECG data can be quickly and easily analyzed and provided to medical staff through our proprietary analyzer app. In addition, the patch is highly adhesive and dust and water-resistant (IP44/IP57), allowing users to go about their daily activities, such as working and walking while wearing the patch, as well as showering and light exercising, ATsens said.

"The role of AT-Patch is to catch signs of heart disease wherever and whenever they may appear," ATsens CEO Jeong Jong-ook said. “We are pleased to effectively detect arrhythmias even during the rigors of Mt. Everest and contribute to the successful completion of clinical trials in extreme environments. We look forward to expanding the use of AT-Patch in various medical applications, including point-of-care and academic research, both domestically and internationally."

According to ATsens, the company has set various records in the domestic and international markets based on its unique technology. The company was the first in the world to enter the Japanese market with its wearable ECG device, distributing AT-Patch to more than 113 Japanese general hospitals in just nine months. In addition, the company has completed overseas distributor and export contracts totaling more than 48 billion won ($35.3 million) with 17 countries, including Germany and Switzerland. It is continuing to hold export discussions with 10 countries, including the U.S. and Spain.

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