AliveCor Launches Clinical Trial for Remote Atrial Fibrillation Monitoring Using Smartphone-Connected ECG Device

Digital health company AliveCor is preparing to conduct a clinical effectiveness trial for its project, which features a smartphone-connected electrocardiogram (ECG) device. According to ClinicalTrials.gov, the registry website under the U.S. National Institutes of Health, AliveCor will randomly recruit 300 participants at Columbia University to test the product’s capability for remote monitoring of atrial fibrillation.

Monitoring devices offer rapid diagnostic capabilities, helping patients better understand their medical conditions.

AliveCor’s device is a wireless, single-lead mobile electrocardiogram (ECG) monitor attached to the back of a smartphone. It records heart rate, provides diagnostic insights within 12 seconds of data acquisition, stores the readings on an iPhone, and uploads them to a cloud-based server accessible to both patients and physicians. The device received FDA approval in 2012 and is compatible with iPhone, iPad, and Android devices. AliveCor collects approximately 130,000 ECG recordings per month. Notably, 70% of users continue to use the device regularly after six months. Additionally, AliveCor offers the AliveECG app, which connects to the device, enabling patients to conveniently monitor their health status at any time.

Atrial fibrillation is the most common sustained arrhythmia. Its incidence increases with age, reaching up to 10% in individuals over 75 years old. During atrial fibrillation, the atrial activation rate ranges from 300 to 600 beats per minute. In patients with atrial fibrillation, the atria lose their effective contractile function, resulting in a heart rhythm that is often rapid and irregular; it is not only significantly faster than that of healthy individuals but also absolutely irregular. Due to the loss of atrial contraction, blood tends to stasis within the atria, leading to thrombus formation. These thrombi can dislodge and travel through the bloodstream to various parts of the body, causing complications such as cerebral embolism and peripheral arterial embolism.

A clinical trial researcher stated, “Atrial fibrillation is a condition characterized by an irregular heart rate and represents a serious health concern. The long-term goal of AliveCor’s project is to leverage this mobile-compatible cardiac health monitor to help patients better understand their recurrent episodes of atrial fibrillation and enhance their ability to manage their health.”

The trial was conducted jointly by a specialized research team and interdisciplinary experts.

The trial is scheduled for completion in August 2018, utilizing AliveCor’s monitoring devices throughout. The study involves 300 patients with a history of atrial fibrillation. Among them, 150 participants will be provided with iPhones equipped with atrial fibrillation detection capabilities and will receive text messages offering professional medical guidance, while the remaining 150 patients will continue their usual pharmacological treatment. This comparative trial will last for six months.

The researcher stated, “The medical guidance information provided to trial participants pertains to their atrial fibrillation and underlying cardiovascular risk factors. This information was developed by a specialized research group in collaboration with an interdisciplinary team of experts from the American Heart Association.”

This trial will compare the periodic arrhythmia, treatment duration, and therapeutic efficacy between the two groups. It will also assess factors that indirectly reflect treatment outcomes, such as quality of life and knowledge about atrial fibrillation, through questionnaire surveys.

In the summer of 2015, AliveCor conducted a small-scale trial in Utah, United States, selecting 50 individuals suspected of having ST-elevation myocardial infarction (STEMI) for device testing. STEMI is a common type of heart disease caused by blocked blood supply to the heart.

AliveCor hopes that individuals with serious cardiac conditions will use its monitor and the AliveECG app to continuously monitor their health status.

Euan Thomsen, CEO of AliveCor, stated: “We firmly believe that if people are willing to use this product regularly, particularly those at risk aged 40 and above, they can leverage mobile technology to detect previously undiagnosed atrial fibrillation.”

Connect with Apple HealthKit; the new product is a wristband integrated with a smartwatch.

In March this year, AliveCor renamed its mobile cardiac monitoring device to “Kardia Mobile.” The company stated that new features have been added to Kardia Mobile, including compatibility with Apple’s HealthKit.

Meanwhile, AliveCor released a hardware device compatible with the Apple Watch, named “KardiaBand.” This device is an electrocardiogram (ECG) monitor with integrated dual electrodes, designed as a flexible wristband that allows users to monitor their heart condition simply by wearing it on their wrist. The cardiac monitoring accessory connects wirelessly to the smartwatch via ultrasound, which reduces power consumption by 92% compared to Bluetooth and enables faster data transmission. However, this wristband has not yet received FDA clearance.

Author: Xueyuan Deng

Responsible Editor: Li Simeng

AliveCor's Third-Generation Product Sees 60% Price Cut

[Overseas Internet Healthcare Startup Case] AliveCor: From Medical Device Manufacturing to Data Value Extraction