RECRUITINGINTERVENTIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

Right Ventricular Pacing

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. All devices used in this study are commercially available in the European Union and carry a valid CE mark.

DEVICE

Left Bundle Branch Pacing

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. All devices used in this study are commercially available in the European Union and carry a valid CE mark.

Locations (1)

University General Hospital of Patras

Pátrai, Greece