Arrhythmias & electrophysiology
ealtime Diagnosis from lectrocardiogram Artificial Intelligence- uided Screening for trial Fibrillation with ong Follow-Up (REGAL): Rationale and design of a pragmatic, decentralized, randomized controlled trial
Study context
- Population
- Older adults at high likelihood of unrecognized atrial fibrillation (AF) by AI-ECGplanned
- Participants
- 2,000 adults
- Planned comparison
- Apple Watch long-term monitoring vs control
- Primary endpoint
- Newly diagnosed AF
- Follow-up
- 2 years
Methodological detailsREGAL, pragmatic, decentralized, 1:1 randomized, Remote consent and follow-up without travel to study sites, Secondary outcomes: change in cognitive function, stroke, major bleeding, all-cause mortality
- REGAL
- Pragmatic
- Decentralized
- 1:1 randomized
- Remote consent and follow-up without travel to study sites
- Secondary outcomes: change in cognitive function, stroke, major bleeding, all-cause mortality
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
ealtime Diagnosis from lectrocardiogram Artificial Intelligence- uided Screening for trial Fibrillation with ong Follow-Up (REGAL): Rationale and design of a pragmatic, decentralized, randomized controlled trial. Am Heart J. Published 30 October 2023. doi:10.
Summarised from the published abstract; every number is checked against it