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.
Sinus node dysfunction (SND) is a common indication for permanent pacemaker implantation. Conventional right atrial appendage (RAA) pacing may result in delayed or dyssynchronous atrial activation, potentially increasing the risk of atrial arrhythmias. Posterosuperior bundle (PSB) pacing is a novel physiological atrial pacing approach. This study is a prospective, multicenter, open-label, randomized controlled trial. A total of approximately 300 eligible SND patients indicated for pacemaker implantation will be enrolled and randomly assigned (1:1) to PSB pacing or RAA pacing. Ventricular pacing will be performed using left bundle branch area pacing in both groups. Following implantation, the pacemaker will be programmed in DDD mode with a lower rate of 70 beats/min during daytime and 60 beats/min during nighttime. Rate-responsive pacing will be enabled by default when available; ATP will be disabled by default. Participants will be followed at 3, 6, 12, and 24 months after implantation. The primary endpoint is the occurrence of AF episodes lasting ≥6 minutes. Secondary endpoints include atrial high-rate episodes, AF burden, pacing parameters, ECG and echocardiographic indices, laboratory findings, and mortality outcomes. Safety endpoints include procedural complications and device-related adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
Atrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary.
Atrial pacing lead implanted at the posterosuperior bundle region. Left bundle branch area pacing will be applied if ventricular pacing is necessary.
China Medical University affiliated AnQing Municipal Hospital
Anqing, Anhui, China
NOT_YET_RECRUITINGTongling People's Hospital
Tongling, Anhui, China
NOT_YET_RECRUITINGAffiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, China
NOT_YET_RECRUITINGWuhan Asia General Hospital
Wuhan, Hubei, China
NOT_YET_RECRUITINGTong Ren Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGFudan University affiliated Huadong Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShanghai Jiaotong University affiliated Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShanghai Jiaotong University affiliated Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShanghai University of Traditional Chinese Medicine affiliated Putuo Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGTongji University School of Medicine affiliated Tongji University
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGIncidence of atrial fibrillation
Incidence of atrial fibrillation ≥ 6 minutes during follow-ups
Time frame: From implantation to regular follow-ups up to 24 months
Atrial high-rate episodes
Time frame: From implantation to regular follow-ups up to 24 months
AF burden
Time frame: From implantation to regular follow-ups up to 24 months
Intrinsic P-wave duration
Measured from the onset of the P wave to the end
Time frame: At baseline and regular follow-ups up to 24 months, when intrinsic atrial rhythm is assessable
Paced P-wave duration
Measured from the pacing stimulus to P wave end duration
Time frame: From implantation to regular follow-ups up to 24 months
Left ventricular ejection fraction (LVEF)
Standard transthoracic echocardiographic parameter
Time frame: At baseline, 6-, 12-, and 24-month follow-ups
Left atrial diameter (LAD)
Standard transthoracic echocardiographic parameter
Time frame: At baseline, 6-, 12-, and 24-month follow-ups
Right atrial diameter (RAD)
Standard transthoracic echocardiographic parameter
Time frame: At baseline, 6-, 12-, and 24-month follow-ups
Left ventricular end-systolic diameter (LVESD)
Standard transthoracic echocardiographic parameter
Time frame: At baseline, 6-, 12-, and 24-month follow-ups
Left ventricular end-diastolic diameter （LVEDD）
Standard transthoracic echocardiographic parameter
Time frame: At baseline, 6-, 12-, and 24-month follow-ups
E/e'
Standard transthoracic echocardiographic parameter
Time frame: At baseline, 6-, 12- , 24-month follow-ups
Mitral regurgitation severity
Standard transthoracic echocardiographic measurement using standard semi-quantitative grading (none/trace, mild, moderate, or severe)
Time frame: At baseline, 6-, 12- , 24-month follow ups
Tricuspid regurgitation severity
Standard transthoracic echocardiographic measurement using standard semi-quantitative grading (none/trace, mild, moderate, or severe)
Time frame: At baseline, 6-, 12-, 24- month follow-ups
NT-pro BNP
Standard transthoracic echocardiographic parameter
Time frame: At baseline, before discharge, and 6-month follow-up
eGFR
Time frame: At baseline, before discharge, and 6 - month follow-up
All-cause mortality
Time frame: From implantation to regular follow-ups up to 24 months
Cardiovascular death
Time frame: From implantation to regular follow-ups up to 24 months
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