DEFINE AFib (Atrial Fibrillation)

NCT ID: NCT04926857

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 973 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-21
• Study Completion Date: 2024-01-25

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Non-Interventional

Non-Interventional

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Piccini, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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

Massachusetts General Hospital

Boston, Massachusetts, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

Cooper University Hospital

Camden, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States

Huntington Hospital

Huntington, New York, United States

NYU Langone Hospital Long Island

Mineola, New York, United States

White Plains Hospital Medical Center

White Plains, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cone Health

Greensboro, North Carolina, United States

Oklahoma Heart Hospital Research Foundation

Oklahoma City, Oklahoma, United States

St. Luke's Cardiology Associates

Bethlehem, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Stern Cardiovascular Foundation

Germantown, Tennessee, United States

Ascension Seton Heart Institute Clinical Research

Austin, Texas, United States

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MDT20024

Identifier Type: -

Identifier Source: org_study_id