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Posterosuperior Bundle Pacing for Prevention of Atrial Fibrillation in Patients With Sinus Node Dysfunction (PSB-AF)

2026年8月3日 更新者：Shanghai Tong Ren Hospital

A Prospective, Multicenter, Randomized Controlled Trial Evaluating the Effect of Posterosuperior Bundle Pacing on Atrial Fibrillation Prevention in Patients With Sinus Node Dysfunction

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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. 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.

研究类型

介入性

注册 (估计的)

300

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Anhui
      • Anqing、Anhui、中国
        • China Medical University affiliated AnQing Municipal Hospital
        • 接触：
          • Liangchuan Chen
          • 电话号码：+86 13956556381
          • 邮箱：aqslyy@163.com
      • Tongling、Anhui、中国
        • Tongling People's Hospital
        • 接触：
    • Guizhou
      • Zunyi、Guizhou、中国
        • Affiliated Hospital of Zunyi Medical College
        • 接触：
    • Hubei
      • Wuhan、Hubei、中国
        • Wuhan Asia General Hospital
        • 接触：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200336
        • Tong Ren Hospital, Shanghai Jiaotong University School of Medicine
        • 接触：
      • Shanghai、Shanghai Municipality、中国
        • Fudan University affiliated Huadong Hospital
        • 接触：
      • Shanghai、Shanghai Municipality、中国
        • Shanghai Jiaotong University affiliated Shanghai Ninth People's Hospital
        • 接触：
      • Shanghai、Shanghai Municipality、中国
        • Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital
        • 接触：
      • Shanghai、Shanghai Municipality、中国
        • Shanghai University of Traditional Chinese Medicine affiliated Putuo Hospital
        • 接触：
          • Zongjun Liu
          • 电话号码：+86 19821577439
          • 邮箱：lzj72@126.com
      • Shanghai、Shanghai Municipality、中国
        • Tongji University School of Medicine affiliated Tongji University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：PSB pacing
Patients were randomly assigned to receive posterosuperior bundle pacing for atrial pacing during regular pacemaker implantation procedures.
程序：PSB pacing
Atrial pacing lead implanted at the posterosuperior bundle region. Left bundle branch area pacing will be applied if ventricular pacing is necessary.
有源比较器：RAA pacing
Patients were randomly assigned to receive right atrial appendage pacing for atrial pacing during regular pacemaker implantation procedures.
程序：RAA pacing
Atrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of atrial fibrillation
大体时间：From implantation to regular follow-ups up to 24 months
Incidence of atrial fibrillation ≥ 6 minutes during follow-ups
From implantation to regular follow-ups up to 24 months

次要结果测量

结果测量
措施说明
大体时间
Atrial high-rate episodes
大体时间：From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
AF burden
大体时间：From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Intrinsic P-wave duration
大体时间：At baseline and regular follow-ups up to 24 months, when intrinsic atrial rhythm is assessable
Measured from the onset of the P wave to the end
At baseline and regular follow-ups up to 24 months, when intrinsic atrial rhythm is assessable
Paced P-wave duration
大体时间：From implantation to regular follow-ups up to 24 months
Measured from the pacing stimulus to P wave end duration
From implantation to regular follow-ups up to 24 months
Left ventricular ejection fraction (LVEF)
大体时间：At baseline, 6-, 12-, and 24-month follow-ups
Standard transthoracic echocardiographic parameter
At baseline, 6-, 12-, and 24-month follow-ups
Left atrial diameter (LAD)
大体时间：At baseline, 6-, 12-, and 24-month follow-ups
Standard transthoracic echocardiographic parameter
At baseline, 6-, 12-, and 24-month follow-ups
Right atrial diameter (RAD)
大体时间：At baseline, 6-, 12-, and 24-month follow-ups
Standard transthoracic echocardiographic parameter
At baseline, 6-, 12-, and 24-month follow-ups
Left ventricular end-systolic diameter (LVESD)
大体时间：At baseline, 6-, 12-, and 24-month follow-ups
Standard transthoracic echocardiographic parameter
At baseline, 6-, 12-, and 24-month follow-ups
Left ventricular end-diastolic diameter （LVEDD）
大体时间：At baseline, 6-, 12-, and 24-month follow-ups
Standard transthoracic echocardiographic parameter
At baseline, 6-, 12-, and 24-month follow-ups
E/e'
大体时间：At baseline, 6-, 12- , 24-month follow-ups
Standard transthoracic echocardiographic parameter
At baseline, 6-, 12- , 24-month follow-ups
Mitral regurgitation severity
大体时间：At baseline, 6-, 12- , 24-month follow ups
Standard transthoracic echocardiographic measurement using standard semi-quantitative grading (none/trace, mild, moderate, or severe)
At baseline, 6-, 12- , 24-month follow ups
Tricuspid regurgitation severity
大体时间：At baseline, 6-, 12-, 24- month follow-ups
Standard transthoracic echocardiographic measurement using standard semi-quantitative grading (none/trace, mild, moderate, or severe)
At baseline, 6-, 12-, 24- month follow-ups
NT-pro BNP
大体时间：At baseline, before discharge, and 6-month follow-up
Standard transthoracic echocardiographic parameter
At baseline, before discharge, and 6-month follow-up
eGFR
大体时间：At baseline, before discharge, and 6 - month follow-up
At baseline, before discharge, and 6 - month follow-up
All-cause mortality
大体时间：From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Cardiovascular death
大体时间：From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months

其他结果措施

结果测量
措施说明
大体时间
Procedural complications
大体时间：Perioperative
Safety Outcome
Perioperative
Postoperative adverse events
大体时间：From implantation to regular follow-ups up to 24 months
Safety Outcome, including lead-related complications, thromboembolic events, etc.
From implantation to regular follow-ups up to 24 months
Atrial pacing capture threshold
大体时间：From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Atrial sensing amplitude
大体时间：From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Atrial pacing output
大体时间：From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Paced P-wave morphology
大体时间：From implantation to regular follow-ups up to 24 months
positive, negative, notched, and biphasic
From implantation to regular follow-ups up to 24 months
Intrinsic P-wave morphology
大体时间：At baseline, implant, and regular follow-ups up to 24 months when intrinsic atrial rhythm is assessable
positive, negative, notched, and biphasic
At baseline, implant, and regular follow-ups up to 24 months when intrinsic atrial rhythm is assessable

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai Tong Ren Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月14日

初级完成 (估计的)

2029年2月1日

研究完成 (估计的)

2029年2月1日

研究注册日期

首次提交

2026年5月18日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年8月4日

上次提交的符合 QC 标准的更新

2026年8月3日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • PSB-AF

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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