AliveCor has been actively collecting clinical evidence for the monitoring of its smartphone-connected product, the Kardia ECG device. According to the latest news, AliveCor plans to collaborate with Columbia University on a 300-person randomized trial to test the effects of remote monitoring of atrial fibrillation (AF).
The researchers said that atrial fibrillation is a common disorder in the top of the heart and is a common type of disease. The long-term goal of the program is to use personal mobile heart monitoring devices to help patients better understand recurrent atrial fibrillation while giving patients the ability to better manage their disease. All 300 patients enrolled in the study had a history of atrial fibrillation, of which 150 were given an iPhone with monitoring equipment and educational information, and another 150 were taking routine medical measures.
The research is scheduled to be completed in August 2018. The Kardia mobile device consists of two electrodes that can be attached to the back of the phone. 150 subjects were given AliveCor equipment, and ECGs were submitted every day for six months. They also received HIPAA safety information to encourage them to adopt a healthy lifestyle.
The researchers explained that AF-related behavioral change information and potential risk factor information were selected from a textual database developed jointly by the research team and experts from the American Heart Association.
The study will compare data on arrhythmia recurrence rates, treatment outcomes, and treatment time in the two groups of patients. Secondary outcomes also included quality of life and arrhythmia knowledge, both of which were achieved through questionnaires.
Last year, the company conducted a small-scale device trial to test the efficacy of ST-segment elevation myocardial infarction (STEMI), a common type of heart disease caused by blood clots.
Last month, AliveCor renamed its mobile ECG device to the Kardia mobile device and released a second product, the Apple Watch wristband that monitors ECG readings called KardiaBand. However, the wristband has not been released yet because the device has not yet obtained FDA approval. AliveCor also announced that its new features in the Kardia mobile app have been integrated into HealthKit.
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