NCT04926857

DEFINE AFib (Atrial Fibrillation)

DEFINE AFib Atrial Fibrillation - Development of a Predictive Model for Future Health Care Utilization From Measurements Collected From an Implantable Cardiac Monitor.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 973 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

DEFINE AFib is a prospective, observational, post-market clinical study administered to patients via the Medtronic Discovery app platform. This study will enroll approximately 5,000 patients in the United States who have a Reveal LINQ or LINQ II ICM (or future market-released LINQ devices) and an Apple® iPhone® with iOS version 13 or higher. Interested participants will be screened through the Medtronic Discovery app and those eligible will complete an app-based informed consent. Participants will receive health-focused and quality of life surveys at variable timepoints. DEFINE AFib will measure healthcare interactions using administered surveys to identify said interactions. The Medtronic Discovery app will provide participants with a summary of their ICM data. Participants will be followed up to 5 years or to the end of their ICM service life.

Detailed description

The purpose of this study is to evaluate the association between complex patterns of device-detected AF and other summary and episodic measurements collected by the market- released LINQ ICM device and AF-related healthcare utilization, quality of life, AF-related symptoms, and specific clinical outcomes in patients with a market-released LINQ ICM. The Medtronic Discovery app will be used to collect data both (1) via the iPhone® through patient-reported health surveys and Bluetooth-enabled devices connected through the Apple Health app and (2) data accessed through or stored on the phone pertaining to health records, activity, and other lifestyle data. Secondarily, this study will examine associations between clinical procedures, medications and lifestyle actions taken and their impact on device-detected AF. Additionally, this study will help Medtronic evaluate patients' interaction with reports generated from health data collected by the market-released LINQ ICM. This study will improve our understanding of how data from the LINQ family of devices can be used to guide the management of AF patients.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
OTHER	Non-Interventional	Non-Interventional

Timeline

• Start date: 2021-06-21
• Primary completion: 2024-01-25
• Completion: 2024-01-25
• First posted: 2021-06-15
• Last updated: 2025-08-01
• Results posted: 2025-08-01

Locations

26 sites across 1 country: United States