RecruitingNot ApplicableNCT07250529

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


Sponsor

University Hospital of Patras

Enrollment

244 participants

Start Date

Feb 5, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of pacemaker lead placement — Left Bundle Branch Pacing (LBBP) vs. traditional Right Ventricular Pacing (RVP) — to see which better prevents an abnormal heart rhythm called atrial high-rate episodes (AHRE), which can be a precursor to atrial fibrillation (an irregular and often rapid heart rate). **You may be eligible if...** - You are 18 or older - You are scheduled to receive a dual-chamber pacemaker for complete or second-degree heart block - Your heart's pumping function (ejection fraction) is normal (50% or above) - You are in normal sinus rhythm at the start of the study **You may NOT be eligible if...** - You already have a history of atrial fibrillation - You have previously had a procedure to treat atrial fibrillation - Your heart pumping function is below 50% - You have significant heart valve disease or structural heart problems - You already have a pacemaker or other heart device - You have less than 12 months expected survival - You need anti-arrhythmic drugs for reasons unrelated to atrial fibrillation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERight 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.

DEVICELeft 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

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NCT07250529


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