The medtech giant will conduct the atrial fibrillation (AFib) study remotely using data collected from its Linq family of insertable cardiac monitors (ICM) on its Medtronic Discovery App. The goal is to address questions around AFib burden and its impact on patient outcomes, quality of life and healthcare utilization.
Medtronic plans to enroll approximately 5,000 patients 22 years or older and have a history of AFib, have an iPhone and one of the Linq ICMs. It will incorporate both device data and patient-reported data from scheduled patient surveys and the HealthKit along with electronic health record information about medications and cardiac procedures. Study data will be used to enable improved AFib management in the future.
“When it comes to managing atrial fibrillation, there is not a one-size-fits-all approach, and the hope is that Define AFib may give us the tools to help personalize AF management based on a patient’s individual health profile and physiology,” Dr. Jonathan Piccini, chair of the Define AFib Steering Committee, said in a news release. “Define AFib will harness the power of digital health to make fundamental discoveries about how we can manage atrial fibrillation better in each and every one of our patients.”
The first patients of the study were enrolled at Duke University Medical Center in Durham, N.C. and at Florida Electrophysiology Associates in Atlantis, Fla.
“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,” Julie Brewer, president of Cardiovascular Diagnostic and Services, part of Medtronic’s cardiovascular portfolio, said. “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.”