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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 (LBBP-AHRE Trial): A Randomized Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Greece
University General Hospital of Patras
RECRUITING
Pátrai
Contact Information
Primary
GEORGIOS LEVENTOPOULOS
levent2669@gmail.com
+306977786020
Backup
Periklis Davlouros
pdav@upatras.gr
+306986726300
Time Frame
Start Date: 2026-02-05
Estimated Completion Date: 2029-06-20
Participants
Target number of participants: 244
Treatments
Active_comparator: Arm 1: Conventional Right Ventricular Pacing
Procedure: Standard right ventricular septal pacing~Description: Implantation of a dual-chamber pacemaker with the ventricular lead placed in the RV septum.~At follow-up, the ventricular pacing percentage and pacing configuration will be noted.
Active_comparator: Arm 2: Left Bundle Branch Pacing (LBBP)
Procedure: Left bundle branch pacing lead implantation~Description: Implantation of a dual-chamber pacemaker with the ventricular lead placed at the left bundle branch area.~Physiological pacing will be programmed into the devices and, at follow-up, the percentage of spontaneous pacing will be noted.
Sponsors
Leads: University Hospital of Patras

This content was sourced from clinicaltrials.gov