NCT07305194Not yet recruiting
Study of AHRE Burden in Patients Undergoing Bachmann Bundle Area Pacing and Left Bundle Branch Pacing.
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.
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 460 (estimated)
- First submitted
- 18 Nov 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 5 Dec 2027
- Lead sponsor
- University Hospital of Patras
- Diseases
- Atrial fibrillation
- NCT number
- NCT07305194
What you commit to
- Study type: Observational
- Planned participants: 460
- From 1 Jan 2026 to the primary completion date, 5 Dec 2027
- 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
- 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.
Other
- 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.
Who the study is looking for
- 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.
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 | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.