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

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

Recruiting
65 years and older
All
Phase N/A

Overview

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

  • Medicare beneficiary with Traditional or Original Medicare coverage
    • Medicare beneficiary with Medicare Advantage (waitlisted)
    • Authorize electronic access to their healthcare claims data
    • Authorize sharing of device sensor, health, and Heartline app data from their iPhone and Apple Watch (if applicable). This includes Apple Watch and iPhone sensor data that is not publicly available
    • Willing and able to provide informed consent by electronically signing the remote e-consent directly in the Heartline app prior to any study-related activities. Electronically signing the remote e-consent indicates that he/she understands the purpose of, and activities required for the study and is willing to participate for the 2-year Active Engagement Phase, with continued passive collection of their device and healthcare claims data for an additional 1 year in the Post-Engagement Follow-Up Phase
    • Current resident of the US at the time of eligibility screening, defined by self-reported state of residence within the 50 states or the US or District of Columbia
    • Own an iPhone 6s or later with iOS Version 12.2 or later

Exclusion Criteria:

  • Limited life expectancy and/or current diagnosis of terminal cancer
  • Unable to confirm meeting inclusion criteria, including ability to consent and participate in human participant's research
  • Own an Apple Watch Series 0 paired with an iPhone at the time of screening eligibility (these participants are not eligible for any study cohorts [randomized or observational])
  • Have a confirmed diagnosis of Atrial Fibrillation (AF) at study entry and currently taking a direct oral anti-coagulant (DOAC) for less then (<) 30 days, currently taking other anti-coagulant medication(s) for AF other than a DOAC, or currently not taking medication for AF

Study details
    Arrhythmia
    Arrhythmia
    Atrial Fibrillation
    Atrial Fibrillation

NCT04276441

Janssen Scientific Affairs, LLC

16 February 2024

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