Status:
COMPLETED
A Study to Investigate if Early Atrial Fibrillation (AF) Diagnosis Reduces Risk of Events Like Stroke in the Real-World
Lead Sponsor:
Janssen Scientific Affairs, LLC
Collaborating Sponsors:
Apple Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
65+ years
Brief 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 an...
Eligibility Criteria
Inclusion
- 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 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
- 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 than (\<) 30 days, currently taking other anti-coagulant medication(s) for AF other than a DOAC, or currently not taking medication for AF
Key Trial Info
Start Date :
February 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 23 2025
Estimated Enrollment :
34244 Patients enrolled
Trial Details
Trial ID
NCT04276441
Start Date
February 25 2020
End Date
January 23 2025
Last Update
July 18 2025
Active Locations (1)
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1
Evidation Health
San Mateo, California, United States, 94401