NCT04276441Completed
A Study to Investigate if Early Atrial Fibrillation (AF) Diagnosis Reduces Risk of Events Like Stroke in the Real-World
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
Source: ClinicalTrials.gov · Last updated 18 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 34244 (actual)
- First submitted
- 18 Feb 2020
- Start date
- 25 Feb 2020
- Primary completion date
- 23 Jan 2025
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT04276441
What you commit to
- Study type: Observational
- Participants enrolled: 34244
- From 25 Feb 2020 to the primary completion date, 23 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Limited life expectancy and/or current diagnosis of terminal cancer
Other
- 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 \[randomized or observational\])
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Evidation Health Coordinator of this site? Confirm its status | San Mateo | United States | Unknown status |
Related publications
- Direct-to-Participant Enrollment in a Virtual Trial: Lessons Learned From the Heartline Study.JACC Adv · 2026 · PMID 41875816
This page is information, not medical advice. Discuss any trial with your doctor.