University General Hospital of Patras
Pátrai, Greece
Location status: Recruiting
NCT Number: NCT07250529
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.
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All sexes
Interventional
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Pátrai, Greece
Location status: Recruiting
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.
Device Algorithm Specificity: AHREs will be validated by reviewing the stored atrial electrograms (EGMs) for a random sample of at least 20% of detected episodes to confirm atrial origin, exclude oversensing, and differentiate atrial tachycardia from atrial fibrillation-like episodes. Device model-specific detection thresholds, including refractory oversensing behavior, atrial blanking periods, and sensitivity parameters, will be documented and standardized across participants where possible.
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).
LBBP produces a narrower paced QRS, shorter left ventricular activation time, and more synchronous ventricular contraction compared with RV pacing. These electrophysiologic differences may reduce atrial stretch, left atrial pressure, and atrial substrate remodeling, which are mechanisms believed to lower AHRE burden.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Permanent complete heart block Permanent second-degree AV block (Mobitz II or Mobitz I)
Exclusion criteria
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.
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.
Time frame: From pacemaker implantation (or randomization) to 24 months (primary endpoint)
Sum of the durations of all device-detected AHREs with individual episode duration >6 minutes (atrial rate threshold per device diagnostics, typically ≥170 bpm), expressed as total time (minutes/hours). Total analyzable monitoring time will be defined as the interval from implantation to the last successful device interrogation/remote transmission, excluding periods of missing device data.
Time frame: From pacemaker implantation (or randomization) to 24 months (primary endpoint)
Time frame: From pacemaker implantation (or randomization) to 24 months
Time frame: From pacemaker implantation (or randomization) to 24 months
Time frame: From pacemaker implantation (or randomization) to 24 months
Time frame: From pacemaker implantation (or randomization) to 24 months
Time frame: From pacemaker implantation (or randomization) to 24 months
Time frame: From pacemaker implantation (or randomization) to 24 months
Time frame: From pacemaker implantation (or randomization) to 24 months
Atrial fibrillation (AF) will be evaluated using routine interrogation of implanted pacemakers, which provide device-recorded atrial arrhythmia data, including AF burden and episode duration. Permanent atrial fibrillation will be defined according to the ESC Guidelines for Atrial Fibrillation and will require a consensus decision between the treating physician and the patient that the arrhythmia is ongoing. This consensus will also include an agreement to pursue a rate-control strategy with no further attempts to restore or maintain sinus rhythm.
Time frame: From pacemaker implantation (or randomization) to 24 months
Time frame: From pacemaker implantation (or randomization) to 24 months
Time frame: From pacemaker implantation (or randomization) to 24 months
Time frame: From pacemaker implantation (or randomization) to 24 months
Time frame: From pacemaker implantation (or randomization) to 24 months
Time frame: From pacemaker implantation (or randomization) to 24 months
Time frame: From pacemaker implantation (or randomization) to 24 months
Defined as a drop in LVEF of at least 10 percentage points resulting in LVEF <50%, or a relative reduction in global longitudinal strain of at least 15%
Time frame: At baseline and at 12 and 24 months, where available.
NT-proBNP, hsCRP, and troponin
Time frame: At baseline and at 12 and 24 months, where available.
Including left atrial strain, left atrial volume index, interventricular mechanical delay, left ventricular mechanical delay, and global longitudinal strain, in participants with available echocardiographic studies from centers able to perform these measurements.
Time frame: At baseline and at 3,6,12,18 and 24 months
Minnesota living with heart-failure questionnaire
Contact information is provided by the study sponsor or research team.
GEORGIOS LEVENTOPOULOS
CONTACT
Periklis Davlouros
CONTACT
University Hospital of Patras
Other
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
Acronym: LBBP-AHRE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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