NCT07250529Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 244 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 5 Feb 2026
- Primary completion date
- 20 Apr 2029
- Lead sponsor
- University Hospital of Patras
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT07250529
What you commit to
- Study type: Interventional
- Planned participants: 244
- From 5 Feb 2026 to the primary completion date, 20 Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous atrial fibrillation ablation (catheter-based or surgical)
- Requirement for antiarrhythmic therapy for causes other than atrial fibrillation
Other illness
- History of paroxysmal, persistent, or permanent atrial fibrillation
- Sinus node disease
- Significant structural or valvular heart disease
- Existing pacemaker or other cardiac device requiring modification for study participation
- Any condition judged by the investigator to compromise participation or the integrity of study data
Lab values
- LVEF \< 50%
Other
- Transient AV block requiring pacemaker implantation
- Requirement for pacemaker system upgrade during the study period
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University General Hospital of Patras Coordinator of this site? Confirm its status | Pátrai | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.