With the COVID-19 pandemic still making it difficult to initiate studies in research centers, virtual clinical studies have become all the rage—and Medtronic is hopping on the bandwagon.
The medtech giant unveiled its Medtronic Discovery App, which will be used to recruit participants, communicate with them and collect data throughout large-scale clinical studies designed to be conducted remotely.
The app was built on Apple’s ResearchKit framework and also integrates the tech developer’s HealthKit software to track health and fitness data within the app. Its first project will be the DEFINE AFib study, which aims to better understand how patients and care teams manage atrial fibrillation with the use of an implanted heart monitor.
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In addition to needing an iPhone, participants will also need to be currently undergoing treatment with any of Medtronic's LINQ insertable cardiac monitors. The researchers hope to enroll about 5,000 people with a history of afib, age 22 and up, with the first being recruited at Duke University Medical Center and Florida Electrophysiology Associates.
Throughout the study, participants will use the app to fill out scheduled surveys and automatically collect daily health data from the smartphone's built-in tracking abilities and from their connected health monitors.
That information, along with the patients’ electronic health records, will help illustrate how afib affects quality of life, healthcare utilization and overall health outcomes.
“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 [afib] management based on a patient’s individual health profile and physiology,” said Jonathan Paul Piccini, chair of the study’s steering committee and director of cardiac electrophysiology at Duke.
“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,” Piccini added.
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Earlier this year, the FDA approved Medtronic's DiamondTemp irrigated ablation catheter, embedded with diamonds to conduct heat energy, for treating recurrent afib by creating lesions in the heart muscle and pulmonary veins.
And just this month, Medtronic landed an expanded FDA clearance for its Arctic Front cryoablation system. In contrast to the heat-based DiamondTemp system, the cryoablation catheter uses extremely cold temperatures to rapidly cool down heart tissue to silence the abnormal signals that cause an elevated or irregular heartbeat.
The Arctic Front system has been cleared in the U.S. for over a decade. The most recent expansion of that clearance allows it to be used as an initial treatment for recurrent symptomatic paroxysmal afib, rather than only after drug therapies have failed.