The Clinical Outcomes and Therapeutic Effects in Patients With Cardiac Implantable Electronic Device-detected Subclinical and Clinical Atrial Fibrillation.
National Tawan University Hospital
National Taiwan University Hospital
450 participants
Oct 1, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria1
- Device-detected atrial high-rate episodes (AHREs) lasting ≥6 minutes and <24 hours.
Exclusion Criteria4
- Device-detected AHRE ≥24 hours before enrollment. Current treatment with class I or class III antiarrhythmic drugs for atrial arrhythmias.
- Previous catheter ablation for atrial fibrillation or atrial flutter. Planned catheter ablation within the next 3 months. Contraindication to rhythm-control therapy as determined by the treating physician.
- Life expectancy less than 1 year. Severe comorbid illness that may interfere with study participation or follow-up.
- Pregnancy or breastfeeding. Participation in another interventional clinical trial that may affect study outcomes.
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Interventions
Participants 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.
Standard clinical management and cardiovascular risk factor management according to contemporary clinical practice guidelines without a protocol-mandated rhythm-control strategy.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07649109