The DEFINE AFib study will use data collected from the LINQ family of insertable cardiac monitors
Medtronic has launched its first app-based research study to understand the relationship between atrial fibrillation (AF) burden and impact on patient outcomes.
The DEFINE AFib study will use data from the LINQ family of insertable cardiac monitors (ICMs) to address unanswered questions related to AF burden and its impact on patient outcomes.
Medtronic has recruited the first patients in the study at Duke University Medical Centre in Durham, North Carolina and at Florida Electrophysiology Associates in Atlantis.
The company will conduct the DEFINE AFib study using its new Discovery App in coordination with US sites.
The trial, which will recruit up to 5,000 patients, will consist of patients age 22 or older who have a history of AF, an iPhone device and one of the LINQ family of ICMs.
Medtronic cardiovascular portfolio’s 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 enrollment or follow-up. This first-of-its-kind trial paves the way for future app-based studies at Medtronic.”
Medtronic will integrate both device data and patient-reported data derived from scheduled patient surveys and the HealthKit in the study to deliver comprehensive and actionable insights.
The study will also incorporate electronic health record information regarding medications and earlier cardiac procedures.
Aggregated study data will be leveraged using a machine learning approach to facilitate improved AF management in the future.
ResearchKit framework has been used by the company to develop the Discovery App, which leveraged insights from over 100 hours of patient interviews to simplify and customise patient enrollment, data collection, and communication processes.
Extensive app functionality will enable researchers to carry out DEFINE AFib and future large, integrated studies remotely, said the company.