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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early Rhythm Control Strategy

    Other intervention

    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.

  • Usual Care

    Other intervention

    Standard clinical management and cardiovascular risk factor management according to contemporary clinical practice guidelines without a protocol-mandated rhythm-control strategy.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: Rhythm Control StrategyExperimental treatment 1 intervention
Group B: Arm2 (Usual care)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression to Sustained AHRE or Clinical Atrial Fibrillation

Composite endpoint of progression to device-detected atrial high-rate episodes lasting 24 hours or longer, or development of clinically documented atrial fibrillation confirmed by electrocardiography, ambulatory rhythm monitoring, or physician-adjudicated rhythm recordings.

Time frame
Up to 36 months

Secondary outcomes

1

Ischemic Stroke or Systemic Embolism

Ischemic Stroke or Systemic Embolism

Time frame
Up to 36 months
2

Cardiovascular Death

Cardiovascular Death

Time frame
36 months
3

Heart Failure Hospitalization

Heart Failure Hospitalization

Time frame
36 months

Other outcomes

Sponsors and contacts

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