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Study identifier: NCT07649109 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Subclinical Atrial Fibrillation · Cardiac Arrhythmias  ·  Sponsor: National Taiwan University Hospital

PhasePhase 4
Planned participants450
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Research Coordinator Huang  ·  +886-23123456  ·  hchuangster@gmail.com

Always discuss trial participation with your own doctor first.

Locations (1)

National Taiwan University HospitalTaipei, TaiwanRecruiting

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Source record: clinicaltrials.gov/study/NCT07649109