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NCT Number: NCT07250529

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University General Hospital of Patras

Pátrai, Greece

Location status: Recruiting

Location contact

Georgios Leventopoulos

CONTACT

[email protected]

+306977786020

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Right Ventricular Pacing

Device

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.

Left Bundle Branch Pacing

Device

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.

Primary outcomes

  1. Total cumulative AHRE time for device-detected episodes lasting >6 minutes

    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.

Secondary outcomes

  1. Total cumulative time in AHRE episodes with individual episode duration 0 to 6 minutes.

    Time frame: From pacemaker implantation (or randomization) to 24 months (primary endpoint)

  2. Total cumulative time in AHRE episodes with individual episode duration 6 minutes to 6 hours.

    Time frame: From pacemaker implantation (or randomization) to 24 months

  3. Total cumulative time in AHRE episodes with individual episode duration 6 hours to 24 hours.

    Time frame: From pacemaker implantation (or randomization) to 24 months

  4. Total cumulative time in AHRE episodes with individual episode duration >24 hours.

    Time frame: From pacemaker implantation (or randomization) to 24 months

  5. Time to event - for AHRE episodes > 6 min

    Time frame: From pacemaker implantation (or randomization) to 24 months

  6. Incidence of progression to clinically documented atrial fibrillation (paroxysmal or persistent, symptomatic or asymptomatic, confirmed by ECG, Holter, or wearable monitoring).

    Time frame: From pacemaker implantation (or randomization) to 24 months

  7. Time to first clinically documented atrial fibrillation.

    Time frame: From pacemaker implantation (or randomization) to 24 months

  8. Development of permanent atrial fibrillation.

    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.

  9. Time to progression to permanent atrial fibrillation.

    Time frame: From pacemaker implantation (or randomization) to 24 months

  10. Device- or procedure-related complications (e.g., cardiac perforation, pericardial tamponade, pneumothorax, hemothorax, infection requiring antibiotics or system removal, generator or lead malfunction, hematoma).

    Time frame: From pacemaker implantation (or randomization) to 24 months

  11. All-cause mortality.

    Time frame: From pacemaker implantation (or randomization) to 24 months

  12. Hospitalization due to AF

    Time frame: From pacemaker implantation (or randomization) to 24 months

  13. Hospitalization due to HF

    Time frame: From pacemaker implantation (or randomization) to 24 months

  14. Need for cardioversion.

    Time frame: From pacemaker implantation (or randomization) to 24 months

  15. Development of pacing-induced cardiomyopathy (PICM)

    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%

  16. Changes in biomarkers associated with myocardial stress, inflammation, or injury

    Time frame: At baseline and at 12 and 24 months, where available.

    NT-proBNP, hsCRP, and troponin

  17. Changes in structured echocardiographic parameters

    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.

  18. Quality-of-life change assessed using a validated questionnaire during follow-up.

    Time frame: At baseline and at 3,6,12,18 and 24 months

    Minnesota living with heart-failure questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

GEORGIOS LEVENTOPOULOS

CONTACT

[email protected]

+306977786020

Periklis Davlouros

CONTACT

[email protected]

+306986726300

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Nov 26, 2025
Registry last updated
Mar 13, 2026

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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