Medtronic Launches First Application-Based Research Study
Medtronic (NYSE: MDT) today announced that it has launched the application-based Define AFib research study — a first of its kind for the company.
The medical tech giant will conduct the study of atrial fibrillation (AFib) remotely using data collected from its Linq family of insertable heart monitors (ICMs) on its Medtronic Discovery app. The aim is to answer questions regarding the burden of AFib and its impact on patient outcomes, quality of life and healthcare utilization.
Medtronic plans to enroll approximately 5,000 patients 22 years of age or older with a history of AFib who own an iPhone and one of the Linq ICMs. It will integrate both device data and patient-reported data from scheduled patient surveys and the HealthKit, as well as information from electronic health records about medications and cardiac procedures. The data from the study will be used to allow better management of AFib in the future.
“When it comes to managing atrial fibrillation, there is no one-size-fits-all approach, and the hope is that Define AFib can give us the tools to help tailor AF management based on the profile of the patient. individual health and physiology of a patient ‘Dr Jonathan Piccini, Chairman of the Define AFib Steering Committee, said in a Press release. “Define AFib will harness the power of digital health to make fundamental discoveries about how we can better manage atrial fibrillation in each of our patients. “
The first patients in the study were enrolled at Duke University Medical Center in Durham, NC, and Florida Electrophysiology Associates in Atlantis, Florida.
“Traditional in-person clinical studies are critically important to deepening our understanding of how to manage chronic diseases like AF, but they can place many demands on the patients and physicians involved,” Julie Brewer, President of Cardiovascular Diagnostic and Services, which is part of Medtronic’s cardiovascular portfolio, said. “A completely application-based study design, with sophisticated data aggregation capabilities and remote monitoring using the ICM Linq family, allows us to conduct Define AFib without patient enrollment or follow-up. in person. This one-of-a-kind trial paves the way for future application-based studies at Medtronic. “