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

NCT07305194 | Not Yet Recruiting

• 1 other identifier: UHP-LBBP-BBP-AHRE-2025
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

Brief 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. 1.BBAP + LBBP (physiological pacing group)
2. 2.Right Atrial Appendage (RAA) pacing + LBBP
3. 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.

Conditions

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

Keywords

Atrial High-Rate Episodes (AHRE); Subclinical Atrial Fibrillation; Bachmann Bundle Area Pacing (BBAP); Left Bundle Branch Pacing (LBBP); Physiological Pacing; Interatrial Conduction; Atrial Synchrony; P-wave Duration; Atrial Electromechanical Remodeling; Atrial Strain; Left Atrial Reservoir Strain; Inter-atrial Conduction Delay (IACD); Speckle Tracking Echocardiography; Left Atrial Volume Index (LAVI); Atrial Arrhythmias; Device-Detected AF

Outcome Measures

Primary Outcomes (1)

• AHRE burden

  PRIMARY OUTCOME MEASURE Unit of measure : percent (%) AHRE Burden (% of monitored time) Percentage of total monitored time spent in device-detected atrial high-rate episodes (AHRE), as defined by manufacturer diagnostic criteria

  24 months

Secondary Outcomes (7)

• Number of AHRE episodes (0-6 minutes )

  24 months

• Number of AHRE Episodes (6 minutes-24 hours)

  24 months

• Number of AHRE Episodes (>24 hours)

  24 months

• Incidence of Clinically Documented Atrial Fibrillation

  24 months

• Maximum P-Wave Duration

  Baseline, 24 months

Study Arms (3)

Concurrent BBAP + LBBP (total physiological pacing)

RAA pacing + LBBP

Conventional pacing (RAA + RV pacing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University General Hospital of Patras

Pátrai, Achaia, 26500, Greece

Location

Related Publications (15)

• Michael Glikson et al., 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: Developed by the Task Force on cardiac pacing and cardiac resynchronization therapy of the European Society of Cardiology (ESC) With the special contribution of the European Heart Rhythm Association (EHRA), European Heart Journal, Volume 42, Issue 35, 14 September 2021, Pages 3427-3520, https://doi.org/10.1093/eurheartj/ehab364.

  RESULT

• Glotzer TV, Hellkamp AS, Zimmerman J, Sweeney MO, Yee R, Marinchak R, Cook J, Paraschos A, Love J, Radoslovich G, Lee KL, Lamas GA; MOST Investigators. Atrial high rate episodes detected by pacemaker diagnostics predict death and stroke: report of the Atrial Diagnostics Ancillary Study of the MOde Selection Trial (MOST). Circulation. 2003 Apr 1;107(12):1614-9. doi: 10.1161/01.CIR.0000057981.70380.45. Epub 2003 Mar 24.

  PMID: 12668495 RESULT

• Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.

  PMID: 22236222 RESULT

• Yoshimoto D, Sakamoto Y, Uemura Y, Yamaguchi R, Naganawa H, Suzuki T. Comparative assessment of interatrial conduction delay during Bachmann's bundle pacing and right atrial appendage pacing using biatrial strain rate echocardiography. Heart Rhythm. 2025 Nov;22(11):2753-2754. doi: 10.1016/j.hrthm.2024.12.016. Epub 2024 Dec 15. No abstract available.

  PMID: 39681277 RESULT

• Bailin SJ, Adler S, Giudici M. Prevention of chronic atrial fibrillation by pacing in the region of Bachmann's bundle: results of a multicenter randomized trial. J Cardiovasc Electrophysiol. 2001 Aug;12(8):912-7. doi: 10.1046/j.1540-8167.2001.00912.x.

  PMID: 11513442 RESULT

• Johner N, Namdar M, Shah DC. Intra- and interatrial conduction abnormalities: hemodynamic and arrhythmic significance. J Interv Card Electrophysiol. 2018 Aug;52(3):293-302. doi: 10.1007/s10840-018-0413-4. Epub 2018 Aug 20.

  PMID: 30128800 RESULT

• Kawakami H, Ramkumar S, Nolan M, Wright L, Yang H, Negishi K, Marwick TH. Left Atrial Mechanical Dispersion Assessed by Strain Echocardiography as an Independent Predictor of New-Onset Atrial Fibrillation: A Case-Control Study. J Am Soc Echocardiogr. 2019 Oct;32(10):1268-1276.e3. doi: 10.1016/j.echo.2019.06.002. Epub 2019 Aug 26.

  PMID: 31466848 RESULT

• Infeld M, Habel N, Wahlberg K, Meagher S, Meyer M, Lustgarten D. Bachmann bundle potential during atrial lead placement: A case series. Heart Rhythm. 2022 Mar;19(3):490-494. doi: 10.1016/j.hrthm.2021.11.015. Epub 2021 Nov 12. No abstract available.

  PMID: 34775070 RESULT

• Zagoridis K, Koutalas E, Intzes S, Symeonidou M, Zagoridou N, Karagogos K, Spanoudakis E, Kanoupakis E, Kochiadakis G, Dinov B, Dagres N, Hindricks G, Bollmann A, Nedios S. P-wave duration and interatrial block as predictors of new-onset atrial fibrillation: A systematic review and meta-analysis. Hellenic J Cardiol. 2023 Jul-Aug;72:57-64. doi: 10.1016/j.hjc.2023.03.007. Epub 2023 Apr 5.

  PMID: 37028490 RESULT

• Vedage NA, Cronin EM. Effect of pacing site on P wave parameters: Within-patient comparison of right atrial appendage and Bachmann's bundle. J Electrocardiol. 2024 May-Jun;84:9-14. doi: 10.1016/j.jelectrocard.2024.02.006. Epub 2024 Feb 27.

  PMID: 38432160 RESULT

• Shali S, Su Y, Ge J. Interatrial septal pacing to suppress atrial fibrillation in patients with dual chamber pacemakers: A meta-analysis of randomized, controlled trials. Int J Cardiol. 2016 Sep 15;219:421-7. doi: 10.1016/j.ijcard.2016.06.093. Epub 2016 Jun 23.

  PMID: 27371866 RESULT

• Infeld M, Nicoli CD, Meagher S, Tompkins BJ, Wayne S, Irvine B, Betageri O, Habel N, Till S, Lobel J, Meyer M, Lustgarten DL. Clinical impact of Bachmann's bundle pacing defined by electrocardiographic criteria on atrial arrhythmia outcomes. Europace. 2022 Oct 13;24(9):1460-1468. doi: 10.1093/europace/euac029.

  PMID: 35304608 RESULT

• Lemery R, Guiraudon G, Veinot JP. Anatomic description of Bachmann's bundle and its relation to the atrial septum. Am J Cardiol. 2003 Jun 15;91(12):1482-5, A8. doi: 10.1016/s0002-9149(03)00405-3. No abstract available.

  PMID: 12804741 RESULT

• Kreimer F, Gotzmann M. Pacemaker-induced atrial fibrillation reconsidered-associations with different pacing sites and prevention approaches. Front Cardiovasc Med. 2024 Jun 18;11:1412283. doi: 10.3389/fcvm.2024.1412283. eCollection 2024.

  PMID: 38957332 RESULT

• Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.

  PMID: 12782566 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

GEORGIOS LEVENTOPOULOS

CONTACT

+306977786020; levent2669@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Cardiology - Electrophysiology Patras University Hospital, Greece

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 26, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 5, 2027
• Study Completion (Estimated): April 14, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

GR (1)