AliveCor is continuing to build up the clinical evidence for the efficacy of its smartphone-connected Kardia ECG devices. According to a new posting on ClinicalTrials.gov, AliveCor is gearing up to launch a 300-patient randomized trial at Columbia University to test the effect of technology-enabled remote monitoring on atrial fibrillation.
"Atrial fibrillation (AF), a condition where the top chambers of the heart beat irregularly, is a major health problem," researchers wrote in the posting. "The long-term goal of this project is to use a personal, mobile heart monitor to help patients better recognize recurrent AF and improve patients' ability to better manage their condition. A total of 300 patients with a history of AF will be included in the study, with 150 patients receiving an iPhone with the mobile monitoring device and educational text messaging and the remaining 150 patients continuing with their regular medical care."
The study, set to be completed by August 2018, uses AliveCor's Kardia mobile device, which takes the form of a smartphone case with two electrodes attached to the back. One-hundred and fifty of the 300 patients will be given AliveCor devices and instructed to submit an ECG reading daily for six months. They will also receive HIPAA-safe text messages to encourage healthy behavior.
"Behavioral altering messages relating to the participant's AF and underlying cardiac risk factors will be systematically selected from a bank of text messages developed through collaboration by the study team and an expert interdisciplinary panel from the American Heart Association," researchers explain.
The study will compare rates of recurrent arrhythmias between the two groups as well as treatment outcomes and time-to-treatment. The secondary outcomes will include quality of life and knowledge of atrial fibrillation, based on questionnaires administered to the patients.
Last summer, another posting on the site showed AliveCor embarking on a smaller trial with Intermountain Healthcare in Utah. That trial aimed to test the device with 50 patients who have possible ST Elevation Myocardial Infarction (STEMI), a common type of heart attack caused by a blockage of blood supply to the heart.
Just last month, AliveCor rebranded its AliveCor Mobile ECG device as Kardia Mobile and unveiled a second, upcoming hardware product: an Apple Watch strap that can take electrocardiogram readings, called KardiaBand. The strap is not yet commercially available because it still needs to secure FDA-clearance. AliveCor also announced new features for the Kardia Mobile app, including HealthKit connectivity.