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

N/ANot Yet RecruitingNCT07645066

Shanghai Tong Ren Hospital300 enrolled

Overview

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. Participants will be followed at 3, 6, 12, and 24 months after implantation. An interim analysis will be conducted after 100 patients complete the 6-month follow-up. 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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

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

Outcomes

Primary Outcomes

Incidence of atrial fibrillation

Incidence of atrial fibrillation ≥ 6 minutes during follow-ups

Time frame: From implantation to regular follow-ups up to 24 months

Secondary Outcomes

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)