Comparing heart rhythm episodes with two pacemaker pacing sites in adults without atrial fibrillation
Compares atrial rhythm episodes across pacemaker pacing sites in people without prior atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Study of AHRE Burden in Patients Undergoing Bachmann Bundle Area Pacing and Left Bundle Branch Pacing.
Key facts
- Where
- Pátrai, GreeceSee the site
Where in Greece
- University General Hospital of PatrasPátrai, GreeceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital of Patras
- Trial code
- NCT07305194
- Record updated
- 26 December 2025
- Original description
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.Read full original descriptionShow less
Study of Atrial High-Rate Episode Burden in Patients Undergoing Concurrent Bachmann Bundle Area Pacing and Left Bundle Branch Pacing , Compared With Either Left Bundle Branch Pacing or Conventional Right Ventricular Pacing.
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.
Inclusion: 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: 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); Previous device implantation; 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.