About this trial
Atrial high-rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs) are associated with an increased risk of progression to clinical atrial fibrillation (AF), stroke, heart failure, and mortality. However, optimal management strategies for patients with AHREs lasting between 6 minutes and 24 hours remain uncertain. Current guidelines recommend risk factor modification, but the role of early rhythm-control therapy in preventing AHRE progression has not been well established.
This prospective, randomized, open-label study aims to evaluate whether a rhythm-control strategy combined with optimal risk factor management can reduce progression to sustained AHREs (≥24 hours) or clinical AF compared with optimal risk factor management alone in patients with device-detected AHREs. Eligible participants with CIED-detected AHREs lasting 6 minutes to 24 hours and without prior clinical AF will be randomly assigned to either a rhythm-control group or a usual-care group. The primary endpoint is progression to AHRE duration ≥24 hours or documented clinical AF. Secondary endpoints include stroke, systemic embolism, heart failure hospitalization, cardiovascular death, and all-cause mortality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Early Rhythm Control Strategy
Other interventionParticipants assigned to the early rhythm-control strategy will receive antiarrhythmic drug therapy according to contemporary clinical practice guidelines and physician discretion. Comprehensive cardiovascular risk factor management will be provided throughout the study.
Usual Care
Other interventionStandard clinical management and cardiovascular risk factor management according to contemporary clinical practice guidelines without a protocol-mandated rhythm-control strategy.
Treatment groups
Trial outcomes
Primary outcomes
Progression to Sustained AHRE or Clinical Atrial Fibrillation
Composite endpoint of progression to device-detected atrial high-rate episodes lasting 24 hours or longer, or development of clinically documented atrial fibrillation confirmed by electrocardiography, ambulatory rhythm monitoring, or physician-adjudicated rhythm recordings.
Secondary outcomes
Ischemic Stroke or Systemic Embolism
Ischemic Stroke or Systemic Embolism
Cardiovascular Death
Cardiovascular Death
Heart Failure Hospitalization
Heart Failure Hospitalization
Sponsors and contacts
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