An observational study in Atrial Fibrillation, sponsored by Janssen Scientific Affairs, LLC. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Janssen Scientific Affairs, LLC · Observational
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.
The study population includes an older age group in whom the risk of developing Atrial Fibrillation (AF) is increased and who may benefit from a broad, health-focused Engagement Program paired with the irregular rhythm notification (IRN) alert (photoplethysmogram [PPG] sensor based) and electrocardiogram (ECG) sensor of the Apple Watch Series 5 or later.
Exclusion Criteria:
Participants without a history of AF will be randomly assigned into the study to either an Apple Watch/iPhone group or an iPhone group only.
Device: Heart healthy Engagement Program with the Apple Watch Series 5 or later
Participants with a diagnosis of AF taking a direct oral anti-coagulant (DOAC) for at least 30 days will be randomly assigned to Apple Watch/iPhone group or iPhone group only.
Device: Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later
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.
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.
Time from Randomization to Clinical Diagnosis of Atrial Fibrillation (AF)
Time to a clinical diagnosis of AF obtained from healthcare claims database.
Time frame: Up to 3 years
Percent Days Covered (PDC) by Direct Oral Anti-Coagulant (DOAC) Prescription Fills
Percent days of covered prescription DOAC use minus any evidence of no prescription use/refills over the time interval chosen.
Time frame: Up to 3 years
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 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.
Time frame: Up to 3 years
Summary of Total Cost of Care Delivery, Total Health Resource Utilization (HRU), and Cost Effectiveness
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.
Time frame: Up to 3 years
Time to Ischemic stroke/TIA
Ischemic stroke/TIA is defined as a hospitalization/diagnosis for Ischemic stroke/TIA.
Time frame: Up to 3 years
Time to MI
MI is defined as a hospitalization/diagnosis for MI.
Time frame: Up to 3 years
Time to non-CNS Embolism or Thrombosis
Non-CNS embolism or thrombosis is defined as hospitalization for non-CNS thromboembolic events.
Time frame: Up to 3 years
Time to Hospitalization or ED for HF
Hospitalization or ED visit for HF is defined as an in-patient stay or an outpatient ED visit for HF.
Time frame: Up to 3 years
Time to CV Hospitalization
Hospitalization for CV is defined as an in-patient stay for CV disease.
Time frame: Up to 3 years
Time to all-Cause Mortality
All-cause mortality (ACM) is defined as deaths from all (reported) causes.
Time frame: Up to 3 years
Time to Composite Bleeding Events Resulting in Hospitalization
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.
Time frame: Up to 3 years
Time to Hospitalization for Hemorrhagic Stroke
Hospitalization for hemorrhagic stroke is defined as an in-patient stay for a hemorrhagic stroke.
Time frame: Up to 3 years
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Janssen Scientific Affairs, LLC