Posterosuperior Bundle Pacing to Reduce Atrial Fibrillation in Sinus Node Dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter, randomized trial, adults with sinus node dysfunction undergoing pacemaker implantation are assigned to either PSB pacing or conventional right atrial appendage pacing, with left bundle branch area pacing for ventricular support in both groups. The primary goal is to see if PSB pacing lowers episodes of atrial fibrillation lasting six minutes or longer over 24 months. Secondary outcomes include atrial high-rate episodes, AF burden, pacing parameters, ECG/echo findings, laboratory results, and mortality, along with safety endpoints such as procedural complications and device-related events. The study uses a DDD pacemaker mode with structured rate settings and follows patients at 3, 6, 12, and 24 months. Approximately 300 participants will be enrolled across several Chinese centers.

Why it matters

Who can join: the full rules

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

Where it's running

• Tong Ren Hospital, Shanghai Jiaotong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• 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
• Fudan University affiliated Huadong Hospital
  Shanghai, Shanghai Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Zhaohui Qiu
• Email: qzh3503@shtrhospital.com
• Phone: +862152039999

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Postoperative Atrial Pacing in Children After Heart Surgery

  This study tests whether briefly raising a child’s heart rate after heart surgery improves blood flow and oxygen delivery by using temporary atrial pacing at 10 or 20 beats per minute above the child’s natural rate.

  Recruiting Ann & Robert H Lurie Children's Hospital of Chicago · Chicago, Illinois · NCT07852390

• Immediate effects of different atrial pacing sites on P-wave characteristics

  This study tests whether pacing the atrium from different sites during pacemaker implantation changes the P-wave on ECG to better reflect natural atrial activation.

  Recruiting Shanghai Tong Ren Hospital · Zunyi, Guizhou and 1 other locations · NCT07603648

• BIOTRONIK CSP Lead Registry for Left Bundle Branch Area Pacing

  This registry tests BIOTRONIK’s CSP-based pacing lead in patients needing a pacemaker or CRT, to see how it performs in real-life use.

  Recruiting at 12 sites Biotronik SE & Co. KG · Adelaide and 45 other locations · NCT07393009

• Comparing two pacemaker pacing methods for AV block

  This trial tests whether conduction system (left bundle branch area) pacing or standard right ventricular pacing works better for people with atrioventricular block who need a permanent pacemaker.

  Recruiting at 2 sites University of Tartu · Tallinn, Harju and 1 other locations · NCT07276490

• Simplifying conduction system pacemaker implantation

  This project will try new imaging and electrical mapping methods to make conduction system pacemakers easier to implant and interpret for adults who need ventricular pacing.

  Recruiting Imperial College London · London · NCT07009834

• Evaluating Pacing Dependency After Aortic Valve Replacement

  This study looks at patients who had a heart valve replacement and got a pacemaker to see how well the pacemaker works a year later and what types of heart issues they have.

  Recruiting University Hospital, Montpellier · Montpellier · NCT06756282

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.