DEFINE AFib (Atrial Fibrillation)

Stopped early

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT04926857

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

973

Starts

2021-06-21

Expected to finish

2024-01-25

Last updated by the study team

2025-08-01

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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