The Reveal ICM is designed to be implanted under the skin and continuously record patients’ heart activity, according to a press release.
The 400-subject trial will see patients implanted with the Reveal device for a minimum of 18 months, with 6-month followups.
"Atrial fibrillation is the most common arrhythmia, and with a 5-fold increase in the risk of stroke, the condition carries significant burdens for patients, as well as on the healthcare system," cardiac rhythm disease management president Pat Mackin said in prepared remarks.
The Reveal ICM transmits data via Medtronic’s CareLink network, allowing physicians to read the data remotely, according to the release.
The trial will also evaluate how physicians manage high-risk patients after diagnosis and how to detect AF in patients earlier in the care cycle, Medtronic said.
The company this month touted FDA clearance for its next-generation FlexCath Advance steerable sheath, designed to work with Medtronic’s Arctic Front Advance cryoablation balloon.