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Completed

NCT Number: NCT04276441

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evidation Health

San Mateo, California, 94401, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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 than (<) 30 days, currently taking other anti-coagulant medication(s) for AF other than a DOAC, or currently not taking medication for AF

Treatment and study plan

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

Device

No drug will be given as part of this study. Participants without a diagnosis of AF will be enrolled and a heart healthy Engagement Program delivered via the Heartline app on the iPhone with the Apple Watch Series 5 or later.

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

Device

No drug will be given as part of this study. Participants with a diagnosis of AF (taking a DOAC for at least 30 days) will be enrolled and an Anti-Coagulation Adherence Module delivered via the Heartline app on the iPhone with an Apple Watch Series 5 or later.

Primary outcomes

  1. Time from Randomization to Clinical Diagnosis of Atrial Fibrillation (AF)

    Time frame: Up to 3 years

    Time to a clinical diagnosis of AF obtained from healthcare claims database.

  2. Percent Days Covered (PDC) by Direct Oral Anti-Coagulant (DOAC) Prescription Fills

    Time frame: Up to 3 years

    Percent days of covered prescription DOAC use minus any evidence of no prescription use/refills over the time interval chosen.

Secondary outcomes

  1. Time to Composite of 6-component Events (Ischemic Stroke/TIA, MI, Non-CNS Embolism or Thrombosis, Hospitalization or ED Visit for HF, CV Hospitalization and ACM)

    Time frame: Up to 3 years

    Time to composite of 6-component events (ischemic stroke/transient ischemic attack [TIA], myocardial infarction [MI], non-central nervous system [CNS] embolism or thrombosis, hospitalization or emergency department [ED] visit due to heart failure [HF], cardiovascular [CV] hospitalization, and all-cause mortality [ACM]), obtained from randomization in the healthcare claims database, will be reported.

  2. Summary of Total Cost of Care Delivery, Total Health Resource Utilization (HRU), and Cost Effectiveness

    Time frame: Up to 3 years

    Summary of total cost of care delivery, total HRU, and cost effectiveness will be reported. Total costs of care reported as number of HRU events times the unit cost for each event. HRU reported as counts of HRU events. Cost effectiveness to be assessed by including the cost to diagnosis, treatment and reported clinical outcome.

  3. Time to Ischemic stroke/TIA

    Time frame: Up to 3 years

    Ischemic stroke/TIA is defined as a hospitalization/diagnosis for Ischemic stroke/TIA.

  4. Time to MI

    Time frame: Up to 3 years

    MI is defined as a hospitalization/diagnosis for MI.

  5. Time to non-CNS Embolism or Thrombosis

    Time frame: Up to 3 years

    Non-CNS embolism or thrombosis is defined as hospitalization for non-CNS thromboembolic events.

  6. Time to Hospitalization or ED for HF

    Time frame: Up to 3 years

    Hospitalization or ED visit for HF is defined as an in-patient stay or an outpatient ED visit for HF.

  7. Time to CV Hospitalization

    Time frame: Up to 3 years

    Hospitalization for CV is defined as an in-patient stay for CV disease.

  8. Time to all-Cause Mortality

    Time frame: Up to 3 years

    All-cause mortality (ACM) is defined as deaths from all (reported) causes.

  9. Time to Composite Bleeding Events Resulting in Hospitalization

    Time frame: Up to 3 years

    Hospitalization for composite bleeding events (such as intracranial hemorrhage, gastrointestinal [GI], respiratory, intraocular) is defined as in-patient stay for bleeding events, as reported in the healthcare claims database.

  10. Time to Hospitalization for Hemorrhagic Stroke

    Time frame: Up to 3 years

    Hospitalization for hemorrhagic stroke is defined as an in-patient stay for a hemorrhagic stroke.

Sponsors and collaborators

Lead sponsor

Janssen Scientific Affairs, LLC

Industry

Collaborators

  • Apple Inc.

Registry information

Official study title

HEARTLINE - A Heart Health Study Using Digital Technology to Investigate if Early AF Diagnosis Reduces the Risk of Thromboembolic Events Like Stroke IN the Real-world Environment

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2020
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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