Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07250529

Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF

Led by University Hospital of Patras · Updated on 2026-03-13

244

Participants Needed

1

Research Sites

175 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This prospective, randomized controlled trial aims to evaluate the effect of left bundle branch pacing (LBBP) compared with conventional right ventricular (RV) pacing on the cumulative duration (total time) of atrial high-rate episodes (AHREs) in patients with preserved left ventricular ejection fraction (LVEF) who are expected to require frequent ventricular pacing. Atrial High-Rate Episodes (AHREs) are defined as episodes of atrial tachyarrhythmia that are automatically recorded by device diagnostics and detected by implanted cardiac devices. These episodes usually have an atrial rate ≥170 beats per minute and a duration ≥6 minutes. AHREs are linked to a higher risk of thromboembolic events and clinical atrial fibrillation (AF), and they may indicate subclinical AF or other atrial tachyarrhythmias. Chronic RV pacing has been linked to mechanical and electrical dyssynchrony, which may encourage atrial remodeling and the development of AF. LBBP provides a more physiological ventricular activation and may reduce atrial tachyarrhythmia time (AHRE time). Patients with LVEF \>50% and atrioventricular (AV) conduction disorders requiring a dual-chamber pacemaker will be randomized to either conventional RV septal pacing or LBBP.

CONDITIONS

Official Title

Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Scheduled implantation of a dual-chamber pacemaker for permanent complete heart block or permanent second-degree AV block (Mobitz II or Mobitz I)
  • Documented preserved left ventricular ejection fraction of 50% or higher
  • Sinus rhythm at baseline
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • History of paroxysmal, persistent, or permanent atrial fibrillation
  • Previous atrial fibrillation ablation (catheter-based or surgical)
  • Left ventricular ejection fraction below 50%
  • Sinus node disease
  • Transient atrioventricular block requiring pacemaker implantation
  • Significant structural or valvular heart disease
  • Need for pacemaker system upgrade during the study
  • Requirement for antiarrhythmic therapy for causes other than atrial fibrillation
  • Existing pacemaker or cardiac device requiring modification for study participation
  • Enrollment in another clinical trial that could interfere with study endpoints or pacing parameters
  • Contraindication to left bundle branch pacing or related lead implantation
  • Life expectancy less than 12 months
  • Any condition that compromises participation or data integrity as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

University General Hospital of Patras

Pátrai, Greece

Actively Recruiting

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Research Team

G

GEORGIOS LEVENTOPOULOS

CONTACT

P

Periklis Davlouros

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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