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Posterosuperior Bundle Pacing for Prevention of Atrial Fibrillation in Patients With Sinus Node Dysfunction

Sponsor: Shanghai Tong Ren Hospital • ClinicalTrials.gov ID: NCT07645066

Registry updated: 2026-09-23

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Description

This study aims to evaluate whether posterosuperior bundle (PSB) pacing reduces the incidence of atrial fibrillation (AF) in patients with sinus node dysfunction (SND) undergoing pacemaker implantation. Approximately 300 patients will be enrolled and randomized to receive atrial pacing at either the PSB region or the right atrial appendage (RAA). The primary endpoint is the occurrence of AF episodes lasting ≥6 minutes, as detected by device or surface electrocardiogram. Patients will be followed for up to 24 months.

Interventions

RAA pacing (Procedure)
Atrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary.
PSB pacing (Procedure)
Atrial pacing lead implanted at the posterosuperior bundle region. Left bundle branch area pacing will be applied if ventricular pacing is necessary.

Eligibility criteria

Inclusion Criteria: * Age ≥18 years * Indication for permanent pacemaker implantation, including: * Sinus node dysfunction, defined as at least one of the following: * Symptomatic sinus bradycardia * Tachy-brady syndrome * Chronotropic incompetence * Sinus pause / arrest * Atrioventricular block (if present); if ventricular pacing is required, left bundle branch area pacing is planned * Expected survival \>1 year * Panned implantation of a device capable of detecting atrial high-rate episodes * Willing and able to provide informed consent Exclusion Criteria: * Persistent atrial fibrillation (AF) (\>7 days), long-standing persistent AF, permanent AF, or prior atrioventricular node ablation * Prior cardiac implantable electronic device (CIED) requiring replacement, upgrade, or revision * Indication for cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) * Prior cardiac surgery, severe hepatic or renal dysfunction, or other life-threatening systemic diseases * Acute myocardial infarction within 3 months before enrollment * Persistent left superior vena cava or dextrocardia * Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception * Participation in another clinical trial that may interfere * Any condition that, in the opinion of the investigator, makes participation unsuitable

Conditions

Pacing Therapy Cardiac Pacing

Locations

China Medical University affiliated AnQing Municipal Hospital — Anqing, Anhui, China
Tongling People's Hospital — Tongling, Anhui, China
Affiliated Hospital of Zunyi Medical College — Zunyi, Guizhou, China
Wuhan Asia General Hospital — Wuhan, Hubei, China
Tong Ren Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China
Fudan University affiliated Huadong Hospital — Shanghai, Shanghai Municipality, China
Shanghai Jiaotong University affiliated Shanghai Ninth People's Hospital — Shanghai, Shanghai Municipality, China
Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital — Shanghai, Shanghai Municipality, China
Shanghai University of Traditional Chinese Medicine affiliated Putuo Hospital — Shanghai, Shanghai Municipality, China
Tongji University School of Medicine affiliated Tongji University — Shanghai, Shanghai Municipality, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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