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

3 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

300

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Anhui
      • Anqing, Anhui, China
        • China Medical University affiliated AnQing Municipal Hospital
        • Contato:
          • Liangchuan Chen
          • Número de telefone: +86 13956556381
          • E-mail: aqslyy@163.com
      • Tongling, Anhui, China
        • Tongling People's Hospital
        • Contato:
    • Guizhou
      • Zunyi, Guizhou, China
        • Affiliated Hospital of Zunyi Medical College
        • Contato:
    • Hubei
      • Wuhan, Hubei, China
        • Wuhan Asia General Hospital
        • Contato:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200336
        • Tong Ren Hospital, Shanghai Jiaotong University School of Medicine
        • Contato:
      • Shanghai, Shanghai Municipality, China
        • Fudan University affiliated Huadong Hospital
        • Contato:
      • Shanghai, Shanghai Municipality, China
        • Shanghai Jiaotong University affiliated Shanghai Ninth People's Hospital
        • Contato:
      • Shanghai, Shanghai Municipality, China
        • Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital
        • Contato:
      • Shanghai, Shanghai Municipality, China
        • Shanghai University of Traditional Chinese Medicine affiliated Putuo Hospital
        • Contato:
          • Zongjun Liu
          • Número de telefone: +86 19821577439
          • E-mail: lzj72@126.com
      • Shanghai, Shanghai Municipality, China
        • Tongji University School of Medicine affiliated Tongji University
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: PSB pacing
Patients were randomly assigned to receive posterosuperior bundle pacing for atrial pacing during regular pacemaker implantation procedures.
Procedimento: PSB pacing
Atrial pacing lead implanted at the posterosuperior bundle region. Left bundle branch area pacing will be applied if ventricular pacing is necessary.
Comparador Ativo: RAA pacing
Patients were randomly assigned to receive right atrial appendage pacing for atrial pacing during regular pacemaker implantation procedures.
Procedimento: RAA pacing
Atrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Incidence of atrial fibrillation
Prazo: 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

Medidas de resultados secundários

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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Procedural complications
Prazo: Perioperative
Safety Outcome
Perioperative
Postoperative adverse events
Prazo: 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
Prazo: From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Atrial sensing amplitude
Prazo: From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Atrial pacing output
Prazo: From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Paced P-wave morphology
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Shanghai Tong Ren Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

14 de agosto de 2026

Conclusão Primária (Estimado)

1 de fevereiro de 2029

Conclusão do estudo (Estimado)

1 de fevereiro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

18 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de junho de 2026

Primeira postagem (Real)

12 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • PSB-AF

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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