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NCT07645066From ClinicalTrials.govRecruiting

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

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

  • Pacing Therapy
  • Cardiac Pacing

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Shanghai Tong Ren Hospital
Enrolment target
300
Started
25 August 2026
Main results due
1 February 2029
Study sites
10
Registry updated
23 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(10)

  • China Medical University affiliated AnQing Municipal Hospital

    Anqing, Anhui, China

    Not yet recruiting

  • Tongling People's Hospital

    Tongling, Anhui, China

    Not yet recruiting

  • Affiliated Hospital of Zunyi Medical College

    Zunyi, Guizhou, China

    Not yet recruiting

  • Wuhan Asia General Hospital

    Wuhan, Hubei, China

    Not yet recruiting

  • Tong Ren Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

    Recruiting

  • Fudan University affiliated Huadong Hospital

    Shanghai, Shanghai Municipality, China

    Not yet recruiting

  • Shanghai Jiaotong University affiliated Shanghai Ninth People's Hospital

    Shanghai, Shanghai Municipality, China

    Not yet recruiting

  • Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, China

    Not yet recruiting

  • Shanghai University of Traditional Chinese Medicine affiliated Putuo Hospital

    Shanghai, Shanghai Municipality, China

    Not yet recruiting

  • Tongji University School of Medicine affiliated Tongji University

    Shanghai, Shanghai Municipality, China

    Not yet recruiting

Showing 10 of 10 sites. 1 of the 10 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07645066. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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