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

8. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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. An interim analysis will be conducted after 100 patients complete the 6-month follow-up.

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PSB pacing
Patients were randomly assigned to receive posterosuperior bundle pacing for atrial pacing during regular pacemaker implantation procedures.
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.
Aktiv komparator: RAA pacing
Patients were randomly assigned to receive right atrial appendage pacing for atrial pacing during regular pacemaker implantation procedures.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of atrial fibrillation
Tidsramme: 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

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procedural complications
Tidsramme: Perioperative
Safety Outcome
Perioperative
Postoperative adverse events
Tidsramme: 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
Tidsramme: From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Atrial sensing amplitude
Tidsramme: From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Atrial pacing output
Tidsramme: From implantation to regular follow-ups up to 24 months
From implantation to regular follow-ups up to 24 months
Paced P-wave morphology
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai Tong Ren Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. februar 2029

Studieafslutning (Anslået)

1. februar 2029

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • PSB-AF

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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