Is there a safe Atrial Fibrillation(AF) burden? Stroke Risk Across Device-Detected Thresholds in Subclinical AF

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12626001090303

Enrollment

73795

Registered

2026-09-03

Start date

2017-01-19

Completion date

2025-12-19

Last updated

2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Randomised trials of oral anticoagulation(OAC) for subclinical AF(SCAF) have produced modest, discordant results, and whether a specific AF burden threshold identifies patients most likely to benefit from anticoagulation remains unclear. This study aims to characterise the dose-response relationship between AF burden and stroke risk in OAC-naive SCAF, and to determine whether a discrete AF burden threshold predicts ischemic stroke in them, and whether this relationship is modified by clinical risk score

Interventions

Exposure: Atrial fibrillation - subclinical / device detected; Information collected, e.g. medical history, AF Burden, stroke risk, etc. Duration of observation: weekly or biweekly, based on remote transmission data from the available devices, from the period of January 2017 - to December 2025. All the de-identified data will be directly collected from the Pacemate LIVE platform, and participants are not actively involved.

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age > 18 years 2. patients with data linkage for AF burden, ICD codes, and medication/anticoagulation prescriptions 3. dual chamber devices

Exclusion criteria

1. No documented AF burden data 2. Baseline permanent AF 3. Patients with documented atrial flutter only 4. patients with single-chamber devices, loop recorders, subcutaneous and extra-vascular ICDs 5. age<18 yrs 6. Paroxysmal AF and Persistent AF 7. EHR errors 8. missing baseline covariates / no clinical linkage 9. patients with < 1month follow-up

Outcome results