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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

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

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Early Rhythm Control Strategy
  • Usual Care

Treatment groups

450 Participants
are divided into 2 treatment groups