Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07250529

Comparison of Left Bundle Branch Pacing Versus Conventional Right Ventricular Pacing on AHRE Burden in Patients With Preserved Left Ventricular Ejection Fraction and High Ventricular Pacing Dependency

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

244

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating left bundle branch pacing (LBBP) compared with conventional right ventricular (RV) pacing in patients who have preserved left ventricular ejection fraction (LVEF) above 50% and require frequent ventricular pacing due to atrioventricular (AV) conduction disorders. This randomized controlled trial aims to study the total time of atrial high-rate episodes (AHREs), which are episodes of fast heart rhythm detected by implanted devices and linked to risks like atrial fibrillation and thromboembolic events. The study focuses on whether LBBP can reduce AHRE burden better than RV pacing by providing more natural heart activation. Participants are randomly assigned to receive either a dual-chamber pacemaker with the ventricular lead placed in the right ventricular septum or with the lead placed at the left bundle branch area. The devices are commercially available and programmed for physiological pacing. Researchers will monitor pacing percentages and configurations during follow-up visits. The study period lasts 24 months from pacemaker implantation or randomization, during which various episode durations and clinical events will be recorded. During the study, participants will undergo device diagnostics to detect AHREs, with a portion of episodes reviewed to confirm their atrial origin and exclude false readings. Safety events, hospitalizations, changes in heart function, biomarkers, and quality of life will be assessed at multiple time points up to two years. The primary outcome is the total cumulative AHRE time for episodes lasting more than six minutes. This comprehensive monitoring and follow-up will help determine the impact of pacing type on atrial arrhythmias and related health outcomes.

CONDITIONS

Brief 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 for implantation of a dual-chamber pacemaker for permanent complete heart block or permanent second-degree AV block (Mobitz I or Mobitz II)
  • Documented preserved left ventricular ejection fraction (LVEF) 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 AV block requiring pacemaker implantation
  • Significant structural or valvular heart disease
  • Need for pacemaker system upgrade during the study period
  • Requirement for antiarrhythmic therapy for causes other than atrial fibrillation
  • Existing pacemaker or other 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 lead implantation procedure
  • Life expectancy less than 12 months
  • Any condition judged by the investigator to compromise participation or study data integrity

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 day

Participants receive implantation of a dual-chamber pacemaker with the ventricular lead placed either at the left bundle branch area or in the right ventricular septum depending on randomization.

1 implantation visit (in-person)

Monitoring

Duration - 24 months

Participants are monitored for atrial high-rate episodes and pacing performance through device diagnostics over the study period.

Regular follow-up visits at baseline, 3, 6, 12, 18, and 24 months

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

P

Periklis Davlouros

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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Published Research Related To This Trial

Atrial fibrillation burden, episode duration and frequency in relation to quality of life in patients with implantable cardiac monitor.

Victoria Jansson, Lennart Bergfeldt, Jonas Schwieler...

https://pubmed.ncbi.nlm.nih.gov/34036145