Trial results for the DEFINE AFib study in Atrial Fibrillation were posted on 2025-08-01, reporting a 0.76 proportion of healthcare utilization where AF was a reason or suspected reason among 973 enrolled participants.
Background
Atrial Fibrillation (AFib) is the most common sustained cardiac arrhythmia, affecting millions globally. It is characterized by irregular and often rapid heartbeats, which can lead to symptoms such as palpitations, shortness of breath, and fatigue. AFib significantly increases the risk of stroke, heart failure, and other cardiovascular complications, making effective management and monitoring crucial. Understanding healthcare utilization patterns in AFib patients, especially those with implantable cardiac monitors (ICMs), can provide insights into disease burden and the effectiveness of monitoring technologies in real-world settings. The DEFINE AFib study aimed to collect observational data on patients using Medtronic ICMs and an associated app platform.
Trial design
The DEFINE AFib study, an observational, post-market clinical study, was TERMINATED and enrolled 973 participants with Atrial Fibrillation. Participants were administered via the Medtronic Discovery app platform and included patients with a Reveal LINQ or LINQ II ICM (or future market-released LINQ devices) and an Apple iPhone with iOS version 13 or higher. The study aimed to measure healthcare utilization where AF was a reason or a suspected reason for the healthcare interaction.
Key results
The study reported key measurements related to healthcare utilization:
- For "Healthcare Utilization Where AF Was a Reason or a Suspected Reason for the Healthcare Interaction," a proportion of 0.76 was observed for the "Training and Testing Partitions" group.
What this means
The posted results from the terminated DEFINE AFib study provide observational data on healthcare utilization in patients with Atrial Fibrillation using Medtronic ICMs. A proportion of 0.76 for healthcare interactions where AF was a reason or suspected reason suggests a significant impact of AFib on patient healthcare engagement. While this observational data offers insights into real-world patterns, the termination of the study means that the full scope of its intended measurements and analyses may not have been completed. The data contributes to understanding the burden of AFib and the role of monitoring devices in patient care, but further context regarding the study's termination would be necessary for a complete interpretation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04926857, titled "DEFINE AFib (Atrial Fibrillation)", were posted on 2025-08-01 on clinicaltrials.gov.