A Prospective, Multicenter, Randomized Controlled Trial Evaluating the Effect of Posterosuperior Bundle Pacing on Atrial Fibrillation Prevention in Patients With Sinus Node Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- Incidence of atrial fibrillation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PSB pacing
Patients were randomly assigned to receive posterosuperior bundle pacing for atrial pacing during regular pacemaker implantation procedures.
干预措施: PSB pacing (Procedure)
RAA pacing
Patients were randomly assigned to receive right atrial appendage pacing for atrial pacing during regular pacemaker implantation procedures.
干预措施: RAA pacing (Procedure)
结局指标
主要结局
Incidence of atrial fibrillation
时间窗: From implantation to regular follow-ups up to 24 months
Incidence of atrial fibrillation ≥ 6 minutes during follow-ups
次要结局
- AF burden(From implantation to regular follow-ups up to 24 months)
- Atrial high-rate episodes(From implantation to regular follow-ups up to 24 months)
- All-cause mortality(From implantation to regular follow-ups up to 24 months)
- Cardiovascular death(From implantation to regular follow-ups up to 24 months)
- Intrinsic P-wave duration(At baseline and regular follow-ups up to 24 months, when intrinsic atrial rhythm is assessable)
- Paced P-wave duration(From implantation to regular follow-ups up to 24 months)
- Left ventricular ejection fraction (LVEF)(At baseline, 6-, 12-, and 24-month follow-ups)
- Left atrial diameter (LAD)(At baseline, 6-, 12-, and 24-month follow-ups)
- Right atrial diameter (RAD)(At baseline, 6-, 12-, and 24-month follow-ups)
- NT-pro BNP(At baseline, before discharge, and 6-month follow-up)
- Left ventricular end-systolic diameter (LVESD)(At baseline, 6-, 12-, and 24-month follow-ups)
- Left ventricular end-diastolic diameter （LVEDD）(At baseline, 6-, 12-, and 24-month follow-ups)
- E/e'(At baseline, 6-, 12- , 24-month follow-ups)
- Mitral regurgitation severity(At baseline, 6-, 12- , 24-month follow ups)
- Tricuspid regurgitation severity(At baseline, 6-, 12-, 24- month follow-ups)
- eGFR(At baseline, before discharge, and 6 - month follow-up)