AliveCor has new actions to conduct long-term atrial fibrillation monitoring clinical trials

Release date: 2016-04-13

Digital medical company AliveCor is preparing to conduct clinical trials for its project. The company's product is an electrocardiograph device that can be connected to a smartphone. According to information from the National Institutes of Health's registry website ClinicalTrials.gov., AliveCor will randomly search for 300 trials at Columbia University to test the ability of products to remotely monitor atrial fibrillation.

AliveCor's device is a wireless single-lead mobile electrocardiograph that can record heart rate on the back of a smartphone. It can diagnose data within 12 seconds of reading data and store the read data on the iPhone. Upload the data to a cloud-based server that patients and doctors can access. The device was approved by the FDA in 2012 and is compatible with iPhone, iPad and Android devices. AliveCor can get about 130,000 ECG data per month. 70% of users will continue to use it after 6 months of regular use of the device. At the same time, AliveCor has an application called AliveECG that can be connected to the device so that patients can keep an eye on their health.

Atrial fibrillation is the most common persistent arrhythmia. As the incidence of atrial fibrillation increases with age, people over the age of 75 can reach 10%. The frequency of atrial activation during atrial fibrillation is 300-600 beats/min. People with atrial fibrillation lose their effective contractile function. The heart rate is often fast and irregular. It is not only much faster than normal people's heartbeat, but also absolutely untidy. In atrial fibrillation, the atrium loses its contractile function, and the blood is easily stagnated in the atrium to form a blood clot. After the thrombus falls off, it can accompany the blood to all parts of the body, leading to cerebral embolism and limb arterial embolization.

A clinical trial researcher said: "Atrial fibrillation is an irregular heartbeat and a very serious health problem. The long-term goal of the AliveCor project is to use this heart health monitor for mobile devices to help patients better. Get a good understanding of your own atrial fibrillation and improve your ability to solve health problems."

The trial was conducted by a professional research group and interdisciplinary experts

The trial will be completed in August 2018, using AliveCor's monitoring equipment throughout. The trial was conducted by 300 patients with a history of atrial fibrillation. The company provided 150 patients with this type of detectable atrial fibrillation device and sent them text messages for professional medical guidance, while another 150 patients continued to maintain them. The usual way of medication. This comparative test will last for six months.

The researcher said: "The medical guidance information obtained by participating testers is about their atrial fibrillation and basic risk factors for the heart. This information is done by a team of professional researchers and an interdisciplinary team of experts from the American Heart Association."

The trial will compare the periodic arrhythmia, treatment time, and treatment outcomes of the two groups, as well as factors that can indirectly characterize the treatment, such as quality of life and understanding of atrial fibrillation. These will be conducted by questionnaire.

In the summer of 2015, AliveCor conducted a small trial in Utah, USA, which selected 50 people who may have ST-segment elevation myocardial infarction for device testing. ST-end elevation myocardial infarction is a heart Common heart disease caused by blocked blood supply.

AliveCor wants people with serious heart problems to use their monitors to keep their AliveECG application on their health.

Euan Thomsen, CEO of AliveCor, said: "We firmly believe that if people are willing to do this, they can use this product frequently, especially for people over 40 years old, they can use mobile technology to capture previously undiagnosed rooms. trembling."

Connected to Apple HealthKit, the new product is a wristband that combines a smart watch

In March of this year, AliveCor renamed the mobile monitoring heart condition device to "Kardia Mobile," and the company said it has added new features to Kardia Mobile, one of which is to connect to Apple's HealthKit.

At the same time, AliveCor released a hardware device that can be mounted on an Apple Watch, called "KardiaBand", which is an ECG monitor with an integrated dual motor that can be made into a flexible wristband. The user simply monitors the heart condition by wearing it on the wrist. The accessories that monitor the heart and the smart watch are wirelessly connected via ultrasound, which reduces power consumption by 92% compared to Bluetooth and makes data transfer faster. However, this wristband has not been approved by the FDA.

Source: Arterial Network

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