NCT04276441

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34,244 (actual)
• Sponsor: Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Heart healthy Engagement Program 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.
DEVICE	Anti-Coagulation Adherence Module 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.

Timeline

• Start date: 2020-02-25
• Primary completion: 2025-01-23
• Completion: 2025-01-23
• First posted: 2020-02-19
• Last updated: 2025-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study