DEFINE AFib Study Will Leverage Data from Medtronic
Insertable Cardiac Monitors and Medtronic Discovery App™ with the
Goal of Informing Atrial Fibrillation (AF) Management
Strategies
DUBLIN, June 29, 2021 /CNW/ -- Medtronic plc (NYSE:MDT),
the global leader in medical technology, today announced the
initiation of the DEFINE AFib study, the company's first app-based
research study. Using data collected from the LINQ family of
insertable cardiac monitors (ICMs), the study aims to address
unanswered questions around atrial fibrillation (AF) burden and its
impact on patient outcomes, quality of life, and healthcare
utilization. The first patients in the study were enrolled at
Duke University Medical Center in
Durham, N.C., by Jonathan Paul Piccini, M.D., MHS, FHRS, director
of Cardiac Electrophysiology and associate professor of
medicine at Duke University School of
Medicine, and at Florida Electrophysiology Associates in
Atlantis, Fla., by Robert S. Fishel, M.D., founder of the practice
and director of Electrophysiology at JFK Medical Center.
DEFINE AFib will be conducted remotely through the new Medtronic
Discovery App™ in coordination with U.S. sites that collectively
will enroll approximately 5,000 patients. Study participants
will include patients age 22 or older who have a history of AF, an
iPhone device (iOS version 13 or higher), and one of the LINQ
family of ICMs, among other criteria. The study will incorporate
both device data and patient-reported data derived from scheduled
patient surveys and the HealthKit — coupled with electronic health
record information about medications and previous cardiac
procedures — to provide comprehensive, actionable insights. Through
a machine learning approach, aggregated study data will be
leveraged to enable improved AF 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," said Dr.
Piccini, who is also chair of the DEFINE AFib Steering
Committee. "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."
Medtronic developed the app using the ResearchKit framework,
given Apple's commitment to privacy and user-friendly experience.
The app design leveraged insights from more than 100 hours of
patient interviews to simplify and customize patient enrollment,
data collection, and communication processes. Extensive app
functionality will allow researchers to conduct DEFINE AFib and
future large, integrated Medtronic studies remotely, with less site
implementation burden.
"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," said Julie
Brewer, president of the Cardiovascular Diagnostics and
Services business, which is part of the Cardiovascular Portfolio at
Medtronic. "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."
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers the broadest range of
innovative medical technology for the interventional and surgical
treatment of cardiovascular disease and cardiac arrhythmias. The
company strives to offer products and services of the highest
quality that deliver clinical and economic value to healthcare
consumers and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services and
solutions companies – alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
HealthKit and ResearchKit are trademarks of Apple Inc.
registered in the U.S. and other countries. iOS is a registered
trademark of Cisco in the U.S. and is used by Apple under
license.
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SOURCE Medtronic plc