A Study to Investigate if Early Atrial Fibrillation (AF) Diagnosis Reduces Risk of Events Like Stroke in the Real-World

Last updated: July 17, 2025
Sponsor: Janssen Scientific Affairs, LLC
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Atrial Fibrillation

Arrhythmia

Treatment

Heart healthy Engagement Program with the Apple Watch Series 5 or later

Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later

Clinical Study ID

NCT04276441
CR108633
NOPRODAFL0002
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary objectives of this study are to identify and diagnose Atrial Fibrillation (AF), evaluate improvement in cardiovascular (CV) outcomes, improve direct oral anti-coagulant (DOAC) adherence and persistence, and better characterize participants and identify predictors of disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Medicare beneficiary either with Original or Medicare advantage

  • Authorize electronic access to their healthcare claims data

  • Authorize sharing of device sensor, health, and Heartline app data from their iPhoneand Apple Watch (if applicable). This includes Apple Watch and iPhone sensor datathat is not publicly available

  • Willing and able to provide informed consent by electronically signing the remotee-consent directly in the Heartline app prior to any study-related activities.Electronically signing the remote e-consent indicates that he/she understands thepurpose of, and activities required for the study and is willing to participate forthe 2-year Active Engagement Phase, with continued passive collection of theirdevice and healthcare claims data for an additional 1 year in the Post-EngagementFollow-Up Phase

  • Current resident of the US at the time of eligibility screening, defined byself-reported state of residence within the 50 states or the US or District ofColumbia

  • Own an iPhone 6s or later with iOS Version 12.2 or later

Exclusion

Exclusion Criteria:

  • Limited life expectancy and/or current diagnosis of terminal cancer

  • Unable to confirm meeting inclusion criteria, including ability to consent andparticipate in human participant's research

  • Own an Apple Watch Series 0 paired with an iPhone at the time of screeningeligibility (these participants are not eligible for any study cohorts [randomizedor observational])

  • Have a confirmed diagnosis of Atrial Fibrillation (AF) at study entry and currentlytaking a direct oral anti-coagulant (DOAC) for less than (<) 30 days, currentlytaking other anti-coagulant medication(s) for AF other than a DOAC, or currently nottaking medication for AF

Study Design

Total Participants: 34244
Treatment Group(s): 2
Primary Treatment: Heart healthy Engagement Program with the Apple Watch Series 5 or later
Phase:
Study Start date:
February 25, 2020
Estimated Completion Date:
January 23, 2025

Connect with a study center

  • Evidation Health

    San Mateo, California 94401
    United States

    Site Not Available

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