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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура RAA pacing
  Atrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary.
• Процедура PSB pacing
  Atrial pacing lead implanted at the posterosuperior bundle region. Left bundle branch area pacing will be applied if ventricular pacing is necessary.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Atrial high-rate episodes [Срок оценки: From implantation to regular follow-ups up to 24 months]
• AF burden [Срок оценки: From implantation to regular follow-ups up to 24 months]
• Intrinsic P-wave duration [Срок оценки: At baseline and regular follow-ups up to 24 months, when intrinsic atrial rhythm is assessable]
• Paced P-wave duration [Срок оценки: From implantation to regular follow-ups up to 24 months]
• Left ventricular ejection fraction (LVEF) [Срок оценки: At baseline, 6-, 12-, and 24-month follow-ups]
• Left atrial diameter (LAD) [Срок оценки: At baseline, 6-, 12-, and 24-month follow-ups]
• Right atrial diameter (RAD) [Срок оценки: At baseline, 6-, 12-, and 24-month follow-ups]
• Left ventricular end-systolic diameter (LVESD) [Срок оценки: At baseline, 6-, 12-, and 24-month follow-ups]
• Left ventricular end-diastolic diameter （LVEDD） [Срок оценки: At baseline, 6-, 12-, and 24-month follow-ups]
• E/e' [Срок оценки: At baseline, 6-, 12- , 24-month follow-ups]
• Mitral regurgitation severity [Срок оценки: At baseline, 6-, 12- , 24-month follow ups]
• Tricuspid regurgitation severity [Срок оценки: At baseline, 6-, 12-, 24- month follow-ups]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 10 центров

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

Идентификаторы

NCT: NCT07645066 · PSB-AF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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