AliveCor keeps working on proving the efficacy of its smartphone-connected Kardia ECG devices. The company’s latest gig is a 300-patient randomized trial at Columbia University to test the effect of technology-enabled remote monitoring on atrial fibrillation (AF).
“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,” researchers wrote in the trial posting on ClinicalTrials.gov. “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.”
Set to be completed by August 2018, the study will rely on AliveCor’s Kardia mobile device, which comes in the form of a smartphone case with two electrodes attached to the back. Half of the trial participants will be provided with AliveCor devices and instructed to submit an ECG reading daily for six months. They will also receive text messages prepared with the help from the American Heart Association to encourage healthy behavior. The other 150 participants will serve as a control group.
At the end of the study, rates of recurrent arrhythmias between the two groups as well as treatment outcomes and time-to-treatment will be compared. The secondary outcomes will include quality of life and knowledge of atrial fibrillation, based on questionnaires administered to the patients.
Earlier this year, AliveCor rebranded its AliveCor Mobile ECG device as Kardia Mobile and unveiled an Apple Watch strap called KardiaBand that can also take electrocardiogram readings. That strap will be released once FDA give it its seal of approval.