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

NCT07645066 | Not Yet Recruiting

• 1 other identifier: PSB-AF
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Pacing Therapy; Cardiac Pacing

Keywords

Posterosuperior bundle pacing; Right atrial appendage pacing; Physiological pacing; atrial pacing

Outcome Measures

Primary Outcomes (1)

• Incidence of atrial fibrillation

  Incidence of atrial fibrillation ≥ 6 minutes during follow-ups

  From implantation to regular follow-ups up to 24 months

Secondary Outcomes (16)

• Atrial high-rate episodes

  From implantation to regular follow-ups up to 24 months

• AF burden

  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

Other Outcomes (7)

• Procedural complications

  Perioperative

• Postoperative adverse events

  From implantation to regular follow-ups up to 24 months

• Atrial pacing capture threshold

  From implantation to regular follow-ups up to 24 months

Study Arms (2)

PSB pacing

EXPERIMENTAL

Patients were randomly assigned to receive posterosuperior bundle pacing for atrial pacing during regular pacemaker implantation procedures.

Procedure: PSB pacing

RAA pacing

ACTIVE COMPARATOR

Patients were randomly assigned to receive right atrial appendage pacing for atrial pacing during regular pacemaker implantation procedures.

Procedure: RAA pacing

Interventions

RAA pacing PROCEDURE

Atrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary.

RAA pacing

PSB pacing PROCEDURE

Atrial pacing lead implanted at the posterosuperior bundle region. Left bundle branch area pacing will be applied if ventricular pacing is necessary.

PSB pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Tong Ren Hospital: lead

Study Sites (10)

China Medical University affiliated AnQing Municipal Hospital

Anqing, Anhui, China

Location

Tongling People's Hospital

Tongling, Anhui, China

Location

Affiliated Hospital of Zunyi Medical College

Zunyi, Guizhou, China

Location

Wuhan Asia General Hospital

Wuhan, Hubei, China

Location

Tong Ren Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200336, China

Location

Fudan University affiliated Huadong Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Jiaotong University affiliated Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai University of Traditional Chinese Medicine affiliated Putuo Hospital

Shanghai, Shanghai Municipality, China

Location

Tongji University School of Medicine affiliated Tongji University

Shanghai, Shanghai Municipality, China

Location

Central Study Contacts

Zhaohui Qiu

CONTACT

+862152039999; qzh3503@shtrhospital.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)