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

NCT04276441 | Completed DMC FDA Device

• 2 other identifiers: CR108633NOPRODAFL0002
• Study Type: observational
• Target: 34,244
• Locations: 1 country
• Sites: 1

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 and persistence, and better characterize participants and identify predictors of disease.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

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

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

  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.

  Up to 3 years

Secondary Outcomes (10)

• 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)

  Up to 3 years

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

  Up to 3 years

• Time to Ischemic stroke/TIA

  Up to 3 years

• Time to MI

  Up to 3 years

• Time to non-CNS Embolism or Thrombosis

  Up to 3 years

Study Arms (2)

Non- Atrial Fibrillation (AF) Cohort

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

Atrial Fibrillation (AF) Cohort

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

Interventions

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.

Non- Atrial Fibrillation (AF) Cohort

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.

Atrial Fibrillation (AF) Cohort

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Limited life expectancy and/or current diagnosis of terminal cancer
• 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

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: lead
• Apple Inc.: collaborator

Study Sites (1)

Evidation Health

San Mateo, California, 94401, United States

Location

Related Publications (3)

• 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.

  PMID: 40839901 DERIVED

• 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.

  PMID: 36642226 DERIVED

• 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.

  PMID: 34029345 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen Scientific Affairs, LLC Clinical Trial

  Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 19, 2020
• Study Start: February 25, 2020
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

US (1)