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

August 3, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Anqing, Anhui, China
        • China Medical University affiliated AnQing Municipal Hospital
        • Contact:
      • Tongling, Anhui, China
        • Tongling People's Hospital
        • Contact:
    • Guizhou
      • Zunyi, Guizhou, China
        • Affiliated Hospital of Zunyi Medical College
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Wuhan Asia General Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200336
        • Tong Ren Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Fudan University affiliated Huadong Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Shanghai Jiaotong University affiliated Shanghai Ninth People's Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Shanghai University of Traditional Chinese Medicine affiliated Putuo Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Tongji University School of Medicine affiliated Tongji University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PSB pacing
Patients were randomly assigned to receive posterosuperior bundle pacing for atrial pacing during regular pacemaker implantation procedures.
Procedure: PSB pacing
Atrial pacing lead implanted at the posterosuperior bundle region. Left bundle branch area pacing will be applied if ventricular pacing is necessary.
Active Comparator: RAA pacing
Patients were randomly assigned to receive right atrial appendage pacing for atrial pacing during regular pacemaker implantation procedures.
Procedure: RAA pacing
Atrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of atrial fibrillation
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial high-rate episodes
Time Frame: From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
AF burden
Time Frame: From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Intrinsic P-wave duration
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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）
Time Frame: At baseline, 6-, 12-, and 24-month follow-ups
Standard transthoracic echocardiographic parameter
At baseline, 6-, 12-, and 24-month follow-ups
E/e'
Time Frame: At baseline, 6-, 12- , 24-month follow-ups
Standard transthoracic echocardiographic parameter
At baseline, 6-, 12- , 24-month follow-ups
Mitral regurgitation severity
Time Frame: 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
Time Frame: 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
Time Frame: At baseline, before discharge, and 6-month follow-up
Standard transthoracic echocardiographic parameter
At baseline, before discharge, and 6-month follow-up
eGFR
Time Frame: At baseline, before discharge, and 6 - month follow-up
At baseline, before discharge, and 6 - month follow-up
All-cause mortality
Time Frame: From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Cardiovascular death
Time Frame: From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural complications
Time Frame: Perioperative
Safety Outcome
Perioperative
Postoperative adverse events
Time Frame: 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
Time Frame: From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Atrial sensing amplitude
Time Frame: From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Atrial pacing output
Time Frame: From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Paced P-wave morphology
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Tong Ren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 14, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSB-AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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