Medtronic has commenced an app-based research study, DEFINE AFib, to investigate the link between atrial fibrillation (AF) disease burden and its effect on outcomes in patients, their quality of life and use of healthcare.
DEFINE AFib will be carried out remotely using the Medtronic Discovery App and will enrol a total of nearly 5,000 subjects aged 22 years or above with an AF history in the US.
The study will use the data obtained from the LINQ family of insertable cardiac monitors (ICMs).
The first participants were enrolled at Duke University Medical Center in Durham.
Apart from the age criteria, the subjects should have an iPhone device with iOS version 13 or higher, along with one of the LINQ ICMs.
The trial will integrate device data as well as patient-reported data obtained from scheduled patient surveys and the HealthKit to offer complete and actionable insights.
Apple’s HealthKit has electronic health record data on medications merged with data on earlier cardiac procedures.
Leveraging a machine learning method, aggregated study data will be used to facilitate enhanced management of AF in the future.
The app was created by Medtronic utilising Apple’s ResearchKit framework. Its design used insights from nearly 100 hours of patient interviews to streamline and tailor enrolment of patients, collecting data and communication processes.
Furthermore, broad app functionality will aid researchers in carrying out this trial as well as future bigger, remote and integrated Medtronic trials, reducing the burden of trial site implementation.
Medtronic cardiovascular diagnostics and services business president Julie Brewer said: “Traditional, in-person clinical studies are critically important to deepen our understanding of how to manage chronic conditions like AF but can place a lot of demands on the patients and physicians involved.
“A fully app-based study design, with sophisticated data aggregation capabilities and remote monitoring using the LINQ family of ICMs, enables us to conduct DEFINE AFib without in-person patient enrolment or follow-up.”
Last week, Medtronic obtained expanded approval from the US Food and Drug Administration for its Arctic Front Family of Cardiac Cryoablation Catheters to treat recurrent symptomatic paroxysmal AF.