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Recruiting Not applicable

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

NCT07645066 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-08-25
Last updated
2026-09-23

Condition(s) studied

Pacing TherapyCardiac Pacing

Investigational drug(s) / intervention(s)

RAA pacingPSB pacing

RAA pacing: Atrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary.

PSB pacing: Atrial pacing lead implanted at the posterosuperior bundle region. Left bundle branch area pacing will be applied if ventricular pacing is necessary.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of atrial fibrillation — From implantation to regular follow-ups up to 24 months
    Incidence of atrial fibrillation ≥ 6 minutes during follow-ups

Trial sites (10)

FacilityCityRegionStatus
China Medical University affiliated AnQing Municipal Hospital Anqing Anhui Not Yet Recruiting
Tongling People's Hospital Tongling Anhui Not Yet Recruiting
Affiliated Hospital of Zunyi Medical College Zunyi Guizhou Not Yet Recruiting
Wuhan Asia General Hospital Wuhan Hubei Not Yet Recruiting
Tong Ren Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai Municipality Recruiting
Fudan University affiliated Huadong Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Shanghai Jiaotong University affiliated Shanghai Ninth People's Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Shanghai University of Traditional Chinese Medicine affiliated Putuo Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Tongji University School of Medicine affiliated Tongji University Shanghai Shanghai Municipality Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07645066 on ClinicalTrials.gov ↗ ← All trials in China