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

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Incidence of atrial fibrillation [Time frame: From implantation to regular follow-ups up to 24 months]

Secondary outcome measures (12)

• Atrial high-rate episodes [Time frame: From implantation to regular follow-ups up to 24 months]
• AF burden [Time frame: 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]
• Paced P-wave duration [Time frame: 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]
• Left atrial diameter (LAD) [Time frame: At baseline, 6-, 12-, and 24-month follow-ups]
• Right atrial diameter (RAD) [Time frame: 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]
• Left ventricular end-diastolic diameter （LVEDD） [Time frame: At baseline, 6-, 12-, and 24-month follow-ups]
• E/e' [Time frame: At baseline, 6-, 12- , 24-month follow-ups]
• Mitral regurgitation severity [Time frame: At baseline, 6-, 12- , 24-month follow ups]
• Tricuspid regurgitation severity [Time frame: At baseline, 6-, 12-, 24- month follow-ups]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

China · 10 centers

• China Medical University affiliated AnQing Municipal Hospital — Anqing
• Tongling People's Hospital — Tongling
• Affiliated Hospital of Zunyi Medical College — Zunyi
• Wuhan Asia General Hospital — Wuhan
• Tong Ren Hospital, Shanghai Jiaotong University School of Medicine — Shanghai
• Fudan University affiliated Huadong Hospital — Shanghai
• Shanghai Jiaotong University affiliated Shanghai Ninth People's Hospital — Shanghai
• Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital — Shanghai
• … and 2 more centers

Identifiers

NCT: NCT07645066 · PSB-AF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗