DEFINE AFib (Atrial Fibrillation)

Last updated: October 18, 2024
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Overall Status: Completed

Phase

N/A

Condition

Cardiac Disease

Chest Pain

Arrhythmia

Treatment

Non-Interventional

Clinical Study ID

NCT04926857
MDT20024
  • Ages > 22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 973
Treatment Group(s): 1
Primary Treatment: Non-Interventional
Phase:
Study Start date:
June 21, 2021
Estimated Completion Date:
January 25, 2024

Connect with a study center

  • Saint Joseph Heritage Hospital

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Desert Heart Rhythm Consultants

    Palm Springs, California 92262
    United States

    Site Not Available

  • Florida Electrophysiology Associates

    Atlantis, Florida 33462-6614
    United States

    Site Not Available

  • Cardiac Arrhythmia Service

    Boca Raton, Florida 33432
    United States

    Site Not Available

  • University of Florida Health Shands Hospital

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • HCA Healthcare

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Stormont Vail Health Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Norton Heart Specialists

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Jackson Heart Clinic

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Site Not Available

  • The Valley Hospital

    Ridgewood, New Jersey 07450-2726
    United States

    Site Not Available

  • New York Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York 11215
    United States

    Site Not Available

  • Huntington Hospital

    Huntington, New York 11743
    United States

    Site Not Available

  • NYU Langone Hospital Long Island

    Mineola, New York 11501
    United States

    Site Not Available

  • White Plains Hospital Medical Center

    White Plains, New York 10601
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cone Health

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Oklahoma Heart Hospital Research Foundation

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • St. Luke's Cardiology Associates

    Bethlehem, Pennsylvania 18018
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Stern Cardiovascular Foundation

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Ascension Seton Heart Institute Clinical Research

    Austin, Texas 78705
    United States

    Site Not Available

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington 98225
    United States

    Site Not Available

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