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

3. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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. 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.

Studietype

Intervensjonell

Registrering (Antatt)

300

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: PSB pacing
Patients were randomly assigned to receive posterosuperior bundle pacing for atrial pacing during regular pacemaker implantation procedures.
Fremgangsmåte: 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.
Fremgangsmåte: RAA pacing
Atrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Shanghai Tong Ren Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

14. august 2026

Primær fullføring (Antatt)

1. februar 2029

Studiet fullført (Antatt)

1. februar 2029

Datoer for studieregistrering

Først innsendt

18. mai 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • PSB-AF

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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