Not Yet RecruitingNot Applicable

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

Greece460 participantsStarted 2026-01-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients (≥ 18 years) with a clear indication for permanent pacing, according to ESC guidelines \[15\] for the management of conduction disturbances (e.g. symptomatic bradycardia, complete atrioventricular block, sinus node dysfunction). * Sinus rhythm at the time of implantation, with no documented episodes of atrial fibrillation prior to implantation, either in the medical history or in previous recordings (ECG, Holter, telemetry). * Ability to be followed up for at least 24 months after implantation. * Provision of written informed consent to participate in the study. Exclusion Criteria: * History of atrial fibrillation prior to implantation, either permanent or paroxysmal, documented on ECG, Holter, or telemetry. * Prior pharmacological or interventional treatment for AF (e.g. antiarrhythmic drugs, catheter ablation). * Inability to comply with long-term follow-up or non-adherence to follow-up visits. * Contraindications to pacemaker lead placement at the selected sites. * Participation in another study that could influence the results. * Previous device implantation.

What they're measuring

AHRE burden

Timeframe: 24 months

Trial details

NCT IDNCT07305194

SponsorUniversity Hospital of Patras

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-05

Contact for this trial

GEORGIOS LEVENTOPOULOS

+306977786020 levent2669@gmail.com