Left bundle branch pacing versus right ventricular pacing to reduce device‑detected fast atrial episodes in people with preserved ejection fraction
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
This trial will test whether left bundle branch pacing (LBBP) reduces the total time people with preserved ejection fraction spend in device‑detected fast atrial episodes compared with standard right ventricular pacing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital of Patras Academic / other |
| Locations | 1 site (Pátrai) |
| Trial ID | NCT07250529 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized controlled trial comparing physiological left bundle branch pacing (LBBP) to conventional right ventricular (RV) pacing in patients expected to need frequent ventricular pacing and who have preserved left ventricular ejection fraction (LVEF ≥50%). The primary outcome is cumulative duration of atrial high‑rate episodes (AHREs) recorded by implanted devices, with a predefined AHRE definition (atrial rate ≥170 bpm and duration ≥6 minutes) and validation of a random sample of stored atrial electrograms. Patients are randomized at pacemaker implantation to receive either LBBP or conventional RV lead placement and followed with device diagnostics and clinic visits to capture AHRE burden and related events. Key eligibility criteria include sinus rhythm at baseline, indication for dual‑chamber pacemaker for high‑grade AV block, and no prior history of atrial fibrillation or AF ablation.
Who should consider this trial
Good fit: Adults (≥18 years) in sinus rhythm with preserved LVEF (≥50%) who are scheduled for a dual‑chamber pacemaker for permanent complete or high‑grade second‑degree AV block and are expected to require frequent ventricular pacing.
Not a fit: Patients with prior paroxysmal, persistent, or permanent atrial fibrillation, prior AF ablation, reduced LVEF (<50%), sinus‑node disease, significant structural/valvular heart disease, or those requiring device upgrades or antiarrhythmic therapy are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, LBBP could reduce time spent in device‑detected atrial high‑rate episodes and potentially lower subsequent risk of clinical atrial fibrillation and thromboembolic events in paced patients with preserved LVEF.
How similar studies have performed: Observational and small comparative series of physiological pacing (His‑bundle or LBBP) have suggested less ventricular dyssynchrony and lower AF rates versus RV pacing, but randomized data specifically showing reduced AHRE burden are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pátrai
- University General Hospital of Patras — Pátrai, Greece (Recruiting)
Study contacts
- Study coordinator: Georgios Leventopoulos
- Email: levent2669@gmail.com
- Phone: +306977786020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.