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ClinicalTrials.gov ID

NCT07645066

Lead Sponsor

Shanghai Tong Ren HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

300Estimated

Last Update Posted

Aug 4, 2026Actual

Start Date

Aug 14, 2026Estimated

Primary Completion Date

Feb 1, 2029Estimated

Completion Date

Feb 1, 2029Estimated

Official Title

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

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.

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.

• Pacing Therapy
• Cardiac Pacing

• RAA pacing
• PSB pacing

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Shanghai Tong Ren HospitalOTHER

tlph@mail.wh.ah.cn+86 18005669636

wuhanagh@163.com+86 15327298622