Left bundle branch pacing versus right ventricular pacing to reduce device‑detected fast atrial episodes in people with preserved ejection fraction

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

This is a prospective, randomized controlled trial comparing physiological left bundle branch pacing (LBBP) to conventional right ventricular (RV) pacing in patients expected to need frequent ventricular pacing and who have preserved left ventricular ejection fraction (LVEF ≥50%). The primary outcome is cumulative duration of atrial high‑rate episodes (AHREs) recorded by implanted devices, with a predefined AHRE definition (atrial rate ≥170 bpm and duration ≥6 minutes) and validation of a random sample of stored atrial electrograms. Patients are randomized at pacemaker implantation to receive either LBBP or conventional RV lead placement and followed with device diagnostics and clinic visits to capture AHRE burden and related events. Key eligibility criteria include sinus rhythm at baseline, indication for dual‑chamber pacemaker for high‑grade AV block, and no prior history of atrial fibrillation or AF ablation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Scheduled implantation of a dual-chamber pacemaker for:

Permanent complete heart block Permanent second-degree AV block (Mobitz II or Mobitz I)

* Documented preserved LVEF (≥50%)
* Sinus rhythm at baseline
* Ability to provide written informed consent

Exclusion Criteria:

* History of paroxysmal, persistent, or permanent atrial fibrillation
* Previous atrial fibrillation ablation (catheter-based or surgical)
* LVEF \< 50%
* Sinus node disease
* Transient AV block requiring pacemaker implantation
* Significant structural or valvular heart disease
* Requirement 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 LBBP or associated lead implantation procedure
* Life expectancy \< 12 months
* Any condition judged by the investigator to compromise participation or the integrity of study data

Where it's running

• University General Hospital of Patras
  Pátrai, Greece Recruiting

Study contacts

• Study coordinator: Georgios Leventopoulos
• Email: levent2669@gmail.com
• Phone: +306977786020

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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.