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

NCT07305194 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 460

Last updated 2025-12-26

No results posted yet for this study

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.

Conditions

  • Atrial Arrhythmia
  • Atrial Fibrillation (AF)
  • Pacemaker Implantation
  • Left Bundle Branch Pacing
  • Conduction System Pacing

Sponsors & Collaborators

  • University Hospital of Patras

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-05
Completion
2028-04-14

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07305194 on ClinicalTrials.gov