Arrhythmias & electrophysiology
Does early detection of atrial fibrillation reduce the risk of thromboembolic events? Rationale and design of the Heartline study
Study context
- Population
- US adults aged ≥65 years with an iPhone, watch-naïve: without a history of atrial fibrillation (AF), or with AF taking a direct oral anticoagulant (DOAC) for ≥30 daysenrolled
- Participants
- 26,485 adults
- Planned comparison
- Apple Watch plus core digital engagement program (CDEP) vs CDEP alone via iPhone app
- Primary endpoint
- Time from randomisation to clinical diagnosis of AF, confirmed by health care claims
Methodological detailspragmatic, decentralised, application-based, 3:1 randomisation, two randomised cohorts, Key secondary endpoints: claims-based 6-component composite CV/systemic embolism/mortality event, DOAC use and adherence, costs/health resource use, hospitalisations for bleeding, All assessments, including patient-reported outcomes, via the study app
- Pragmatic
- Decentralised
- Application-based
- 3:1 randomisation
- Two randomised cohorts
- Key secondary endpoints: claims-based 6-component composite CV/systemic embolism/mortality event, DOAC use and adherence, costs/health resource use, hospitalisations for bleeding
- All assessments, including patient-reported outcomes, via the study app
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Does early detection of atrial fibrillation reduce the risk of thromboembolic events? Rationale and design of the Heartline study. Am Heart J. Published 12 January 2023. doi:10.
Summarised from the published abstract; every number is checked against it