DEFINE AFib (Atrial Fibrillation)

Terminated

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Healthcare Utilization Where AF Was a Reason or a Suspected Reason for the Healthcare Interaction.	Through study completion (2 years of enrollment, up to 2.6 years of follow-up)	Primary objective is to evaluate whether summary and episodic measurements collected by market-released LINQ ICMs are able to predict increased AF-related healthcare utilization (HCU), which are confirmed healthcare visits in the inpatient hospital, outpatient hospital, clinic/office, emergency department, or other care location (including remote visits) where AF was a reason or suspected reason for healthcare interaction. A predictive model was trained on 70% of the patients with adequate data available and assessed in a validation data set of the remaining 30% of patients, using rolling 60 day blocks. In each block, measurements in the first 30 days were used to predict whether confirmed HCU occurred in the trailing 30 days. Predictive value was assessed using sensitivity, specificity and other measurements within a confusion matrix as well as an area under the receiver operator curve, balancing the sensitivity and specificity. Outcome measure entered here will be AUROC.

Secondary Outcome Measures

Name	Time	Method

Locations (26): Saint Joseph Heritage Hospital
🇺🇸
Mission Viejo, California, United States
Desert Heart Rhythm Consultants
🇺🇸
Palm Springs, California, United States
Florida Electrophysiology Associates
🇺🇸
Atlantis, Florida, United States
Cardiac Arrhythmia Service
🇺🇸
Boca Raton, Florida, United States
University of Florida Health Shands Hospital
🇺🇸
Gainesville, Florida, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
University of Kansas Medical Center
🇺🇸
Kansas City, Kansas, United States
HCA Healthcare
🇺🇸
Overland Park, Kansas, United States
Stormont Vail Health Cotton O'Neil Clinical Research Center
🇺🇸
Topeka, Kansas, United States
Norton Heart Specialists
🇺🇸
Louisville, Kentucky, United States
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Saint Joseph Heritage Hospital
🇺🇸Mission Viejo, California, United States