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Atrial FibrillationNCT04276441

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

An observational study of Atrial Fibrillation, run by Janssen Scientific Affairs, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 and persistence, and better characterize participants and identify predictors of disease. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation
What is being tested?
Heart healthy Engagement Program with the Apple Watch Series 5 or later and Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later
How many people
34,244 participants
Where
1 siteUnited States
Study dates
25 Feb 2020to 23 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Evidation Health

    San Mateo, California, 94401

Other trials in United States

About this study

Official 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

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.

Being tested
Heart healthy Engagement Program with the Apple Watch Series 5 or later, Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heart healthy Engagement Program with the Apple Watch Series 5 or laterDevice

    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 laterDevice

    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.

Study groups in NCT04276441
Study groupRoleWhat they receive
Non- Atrial Fibrillation (AF) CohortParticipants without a history of AF will be randomly assigned into the study to either an Apple Watch/iPhone group or an iPhone group only.
Receives: Device: Heart healthy Engagement Program with the Apple Watch Series 5 or later
Atrial Fibrillation (AF) CohortParticipants 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.
Receives: Device: Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Up to 3 years

  2. 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.

    Measured: Up to 3 years

Secondary outcomes (10)

  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 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.

    Measured: Up to 3 years

  2. 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.

    Measured: Up to 3 years

  3. Time to Ischemic stroke/TIA

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

    Measured: Up to 3 years

  4. Time to MI

    MI is defined as a hospitalization/diagnosis for MI.

    Measured: Up to 3 years

  5. Time to non-CNS Embolism or Thrombosis

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

    Measured: Up to 3 years

  6. 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.

    Measured: Up to 3 years

  7. Time to CV Hospitalization

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

    Measured: Up to 3 years

  8. Time to all-Cause Mortality

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

    Measured: Up to 3 years

  9. 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.

    Measured: Up to 3 years

  10. Time to Hospitalization for Hemorrhagic Stroke

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

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2020
  2. Study start25 Feb 2020
  3. Primary completion23 Jan 2025
  4. Study completion23 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
34,244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04276441
Sponsor's protocol ID
CR108633
Other IDs
NOPRODAFL0002
Status last verified
Jul 2025
First submitted
18 Feb 2020
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
Yes

Publications

  • Hills MT, Korjian S, Chi G, Natale A, Saxon L, Ferdinand KC, Kwaku KF, Brancato S, Hughes A, Baca-Motes K, Steinhubl SR, Wessler J, Goldberg N, Asthana A, Shute K, Applebaum J, Doran K, Nikolovski J, Kaul S, Wentworth D, Damaraju CV, Tavakoli C, Patel M, Curtis AB, Spertus JA, Gibson CM; Heartline Executive Committee and Steering Committee. Direct-to-Participant Enrollment in a Virtual Trial: Lessons Learned From the Heartline Study. JACC Adv. 2026 Apr;5(4):102662. doi: 10.1016/j.jacadv.2026.102662. Epub 2026 Mar 23.

    PubMed 41875816

  • Nikolovski J, Navar AM, Steinhubl S, Baca-Motes K, Curtis AB, Peterson ED, Lakkireddy D, Tarino M, Juan S, Damaraju CRV, Wentworth D, Wildenhaus K, Patel M, Tavakoli C, Gibson CM, Spertus JA; Heartline Steering Committee. The Heartline Experience: Achieving Long-Term Participant Engagement in Digital Health Technology Trials. JACC Adv. 2025 Sep;4(9):102072. doi: 10.1016/j.jacadv.2025.102072. Epub 2025 Aug 20.

    PubMed 40839901

  • Grine M, Guerreiro C, Moscoso Costa F, Nobre Menezes M, Ladeiras-Lopes R, Ferreira D, Oliveira-Santos M. Digital health in cardiovascular medicine: An overview of key applications and clinical impact by the Portuguese Society of Cardiology Study Group on Digital Health. Rev Port Cardiol. 2025 Feb;44(2):107-119. doi: 10.1016/j.repc.2024.08.009. Epub 2024 Oct 10. English, Portuguese.

    PubMed 39393635

  • Gibson CM, Steinhubl S, Lakkireddy D, Turakhia MP, Passman R, Jones WS, Bunch TJ, Curtis AB, Peterson ED, Ruskin J, Saxon L, Tarino M, Tarakji KG, Marrouche N, Patel M, Harxhi A, Kaul S, Nikolovski J, Juan S, Wildenhaus K, Damaraju CV, Spertus JA; Heartline Steering Committee. Does early detection of atrial fibrillation reduce the risk of thromboembolic events? Rationale and design of the Heartline study. Am Heart J. 2023 May;259:30-41. doi: 10.1016/j.ahj.2023.01.004. Epub 2023 Jan 12.

    PubMed 36642226

  • Nikolovski J, Koldijk M, Weverling GJ, Spertus J, Turakhia M, Saxon L, Gibson M, Whang J, Sarich T, Zambon R, Ezeanochie N, Turgiss J, Jones R, Stoddard J, Burton P, Navar AM. Factors indicating intention to vaccinate with a COVID-19 vaccine among older U.S. adults. PLoS One. 2021 May 24;16(5):e0251963. doi: 10.1371/journal.pone.0251963. eCollection 2021.

    PubMed 34029345

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Janssen Scientific Affairs, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from Randomization to Clinical Diagnosis of Atrial Fibrillation (AF) (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04276441, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.

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