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NCT07649109
The Clinical Outcomes and Therapeutic Effects in Patients With Cardiac Implantable Electronic Device-detected Subclinical and Clinical Atrial Fibrillation.
Conditions: Subclinical Atrial Fibrillation, Cardiac Arrhythmias
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 450
Sponsor: National Taiwan University Hospital
Location: National Taiwan University Hospital Taipei
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07649109). StuddyBuddy aggregates publicly available trial information.