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 (part of Johnson & Johnson) · 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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 34,244 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Janssen Scientific Affairs, LLC is the lead sponsor of 41 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Feb 2020 to primary completion in Jan 2025, 58 months.
Of 148 industry-sponsored observational studies under Atrial Fibrillation, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 42. This study's 58 months is above that.
Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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