Clinical Trial

Study of AHRE Burden in Patients Undergoing Bachmann Bundle Area Pacing and Left Bundle Branch Pacing.

Study acronym: AHRE-BLAST
Not Yet Recruiting
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Summary
This prospective observational study evaluates the burden of Atrial High-Rate Episodes (AHRE) in patients without a prior history of atrial fibrillation who undergo concurrent Bachmann Bundle Area Pacing (BBAP) and Left Bundle Branch Pacing (LBBP). Physiological pacing at these sites aims to improve interatrial conduction and reduce the risk of atrial arrhythmias. The study includes a comparative assessment across three patient groups: 1. BBAP + LBBP (physiological pacing group) 2. Right Atrial Appendage (RAA) pacing + LBBP 3. Conventional pacing - RAA and Right Ventricular (RV) pacing AHRE burden will be quantified via device diagnostics and remote monitoring at 3, 12 and 24 months post-implantation. Episodes will be classified by duration (0-6 min, 6-24 h, \>24 h), differentiating subclinical AHRE from clinically documented AF. Secondary analyses include electrocardiographic changes (P-wave indices), the need for antiarrhythmic therapy, and comprehensive echocardiographic evaluation of atrial function (e.g., LA strain, conduction delays, LAVI). The study aims to determine whether physiological pacing (BBAP + LBBP) provides superior protection against AHRE development compared with RAA + LBBP and conventional pacing strategies.
Trial Details
NCT Number NCT07305194
Lead Sponsor University Hospital of Patras
Conditions Atrial Arrhythmia, Atrial Fibrillation (AF), Pacemaker Implantation, Left Bundle Branch Pacing, Conduction System Pacing
Enrollment 460 participants
Start Date 2026-01-01
Primary Completion 2027-12-05 (estimated)
Study Completion 2028-04-14 (estimated)
Updated on ClinicalTrials.gov 2025-12-26