DEFINE AFib (Atrial Fibrillation)

Medtronic Cardiac Rhythm and Heart Failure973 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

973

Conditions

Atrial Fibrillation

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria * Patients with a LINQ ICM who have a self-reported history of AF and who have received an ICM for the following device-logged indications, categorized into the following discrete groups: * AF management: AF management and post-ablation management indications * Suspected AF: Suspected AF and palpitations indications * Stroke: Cryptogenic stroke indication * Individual Access and ability to use an Apple iPhone® compatible with Medtronic's research app (iOS® v. 13.X or higher) * Patient is willing and able to comply with the protocol, including CareLink transmissions (requires adequate connectivity), remotely administered instructions, and remote survey participation * Patient is 22 years of age or older * Located in the United States, with CareLink managed through servers located in United States (50 states or District of Columbia) * Valid email address from self-report at enrollment * Patient must be able to read and write in English Exclusion Criteria Patients with \> 24 months elapsed time from recorded LINQ device implant or \> 48 months elapsed from recorded LINQ II implant date

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

Outcomes

Primary Outcomes

Healthcare Utilization Where AF Was a Reason or a Suspected Reason for the Healthcare Interaction.

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.

Time frame: Through study completion (2 years of enrollment, up to 2.6 years of follow-up)