The Clinical Outcomes and Therapeutic Effects in Patients With Cardiac Implantable Electronic Device-detected Subclinical and Clinical Atrial Fibrillation.

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 Criteria Age ≥18 years. Presence of a cardiac implantable electronic device (CIED), including permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.

Device-detected atrial high-rate episodes (AHREs) lasting ≥6 minutes and \<24 hours.

Ability to provide written informed consent. Willingness and ability to comply with study procedures and follow-up visits. Exclusion Criteria Prior diagnosis of clinical atrial fibrillation, atrial flutter, or atrial tachycardia requiring treatment.

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.

Conditions3

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