Atrial ArrhythmiaAHRE-BLASTNCT07305194

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

An observational study of Atrial Arrhythmia and Atrial Fibrillation (AF), run by University Hospital of Patras at 1 site in Greece.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Arrhythmia, Atrial Fibrillation (AF), Pacemaker Implantation
How many people: 460 participants
Where: 1 siteGreece
Study dates: 1 Jan 2026to 14 Apr 2028
How long will I take part?: 24 Months
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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).

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

GEORGIOS LEVENTOPOULOS contact

+306977786020

levent2669@gmail.com

Greece1 site

University General Hospital of Patras
Pátrai, Achaia, 26500

Other trials in Greece

About this study

Official title: 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.

The study includes a comparative assessment across three patient groups:

BBAP + LBBP (physiological pacing group)
Right Atrial Appendage (RAA) pacing + LBBP
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.

Read the detailed description

Atrial high-rate episodes (AHRE) detected by cardiac implantable devices are associated with an increased risk of developing atrial fibrillation (AF), stroke, and atrial remodeling. Traditional right atrial and right ventricular pacing may alter atrial activation patterns, potentially promoting electrical and structural changes that predispose to atrial arrhythmias.

Physiologic pacing strategies targeting the Bachmann bundle region and the left bundle branch have emerged as alternatives designed to preserve normal conduction pathways. Bachmann Bundle Area Pacing (BBAP) facilitates more synchronous biatrial activation, while Left Bundle Branch Pacing (LBBP) results in near-physiologic ventricular activation. Both methods may reduce conduction delays and improve atrial and ventricular electromechanical function.

This prospective observational study examines whether physiologic atrial and ventricular pacing reduces the burden of device-detected AHRE compared with commonly used pacing configurations. Three groups are evaluated: (1) BBAP combined with LBBP, (2) right atrial appendage pacing combined with LBBP, and (3) conventional right atrial and right ventricular pacing. All enrolled participants have a clinical indication for permanent pacing and no prior diagnosis of AF.

AHRE burden will be assessed through routine device diagnostics and remote monitoring over a 24-month follow-up. Electrocardiographic and echocardiographic data will also be collected to explore relationships between conduction patterns, atrial function, and arrhythmia occurrence. The study aims to clarify whether preserving physiologic conduction pathways influences long-term AHRE burden and may contribute to AF prevention in paced patients.

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
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07305194
Study group	Role	What they receive
Concurrent BBAP + LBBP (total physiological pacing)		Not described
RAA pacing + LBBP		Not described
Conventional pacing (RAA + RV pacing)		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 24 months

Secondary outcomes (7)

Number of AHRE episodes (0-6 minutes )
Device-detected AHRE episodes lasting 0-6 minutes. Unit of measure: Number of episodes
Measured: 24 months
Number of AHRE Episodes (6 minutes-24 hours)
Device-detected AHRE episodes lasting 6 minutes to 24 hours. Unit of Measure: Number of episodes
Measured: 24 months
Number of AHRE Episodes (>24 hours)
Device-detected AHRE episodes lasting more than 24 hours. Unit of measure: Number of episodes
Measured: 24 months
Incidence of Clinically Documented Atrial Fibrillation
Clinically confirmed AF episodes identified via ECG or rhythm strip. Unit of measure : number of events
Measured: 24 months
Maximum P-Wave Duration
Maximum P-wave duration measured on 12-lead ECG Unit of measure : Milliseconds (ms)
Measured: Baseline, 24 months
P - wave axis
Frontal plane P-wave axis measured on 12-lead ECG Unit of Measure: Degrees
Measured: Baseline, 24 months
Initiation or Modification of Antiarrhythmic Therapy
Number of participants requiring initiation or change in antiarrhythmic. Unit of Measure: Number of participants
Measured: Baseline, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202614 Apr 2028

First posted26 Dec 2025
Study start1 Jan 2026 (estimated)
Primary completion5 Dec 2027 (estimated)
Study completion14 Apr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Atrial ArrhythmiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 460 participants (estimated)
Target duration: 24 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT07305194
Sponsor's protocol ID: UHP-LBBP-BBP-AHRE-2025
Acronym: AHRE-BLAST
Status last verified: Dec 2025
First submitted: 18 Nov 2025
Last updated: 26 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
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.
PubMed 12668495
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.
PubMed 22236222
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.
PubMed 39681277
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.
PubMed 11513442
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.
PubMed 30128800
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.
PubMed 31466848
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.
PubMed 34775070
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.
PubMed 37028490
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.
PubMed 38432160
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.
PubMed 27371866
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.
PubMed 35304608
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.
PubMed 12804741
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.
PubMed 38957332
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.
PubMed 12782566

Interested in taking part?

GEORGIOS LEVENTOPOULOS

+306977786020

levent2669@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingObservational study
Registry on Luma Vision's VERAFEYE System (ENLIgHT)
Atrial Fibrillation, Left Atrial Appendage Closure
Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Atrial Fibrillation, Atrial Flutter
Recruiting
Multimodality Location Prediction Accuracy of Leadless Pacemaker Positioning
Sinus Pause, Sinus Sick Syndrome
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation

All Atrial Arrhythmia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT07305194
Acronym / sponsor ID: AHRE-BLAST / UHP-LBBP-BBP-AHRE-2025
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
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 460 participants (estimated)
Lead sponsor: University Hospital of PatrasUniversity, hospital or other
Study start: 1 Jan 2026 (estimated)
Primary completion: 5 Dec 2027 (estimated)
Study completion: 14 Apr 2028 (estimated)
First posted: 26 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study includes a comparative assessment across three patient groups:

BBAP + LBBP (physiological pacing group)
Right Atrial Appendage (RAA) pacing + LBBP
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.

The study aims to determine whether physiological pacing (BBAP + LBBP) provides superior protection against AHRE development compared with RAA + LBBP and conventional pacing strategies.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 24 Months
Number of arms: 3

Arm	Type	Receives
Concurrent BBAP + LBBP (total physiological pacing)	–	–
RAA pacing + LBBP	–	–
Conventional pacing (RAA + RV pacing)	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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).

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

AHRE burden
Time frame: 24 months
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

7 secondary outcomes

Number of AHRE episodes (0-6 minutes )
Time frame: 24 months
Number of AHRE Episodes (6 minutes-24 hours)
Time frame: 24 months
Number of AHRE Episodes (>24 hours)
Time frame: 24 months
Incidence of Clinically Documented Atrial Fibrillation
Time frame: 24 months
Maximum P-Wave Duration
Time frame: Baseline, 24 months
P - wave axis
Time frame: Baseline, 24 months
Initiation or Modification of Antiarrhythmic Therapy
Time frame: Baseline, 24 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
Results publicationMichael 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.
Results publication: PubMed 12668495Glotzer 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.
Results publication: PubMed 22236222Healey 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.
Results publication: PubMed 39681277Yoshimoto 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.
Results publication: PubMed 11513442Bailin 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.
Results publication: PubMed 30128800Johner 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.
Results publication: PubMed 31466848Kawakami 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.
Results publication: PubMed 34775070Infeld 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.
Results publication: PubMed 37028490Zagoridis 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.
Results publication: PubMed 38432160Vedage 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.
Results publication: PubMed 27371866Shali 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.
Results publication: PubMed 35304608Infeld 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.
Individual participant dataSharing planned: Undecided

Related trials for Atrial Arrhythmia

Not yet recruitingObservational study
Registry on Luma Vision's VERAFEYE System (ENLIgHT)
Atrial Fibrillation, Left Atrial Appendage Closure
Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Atrial Fibrillation, Atrial Flutter
Recruiting
Multimodality Location Prediction Accuracy of Leadless Pacemaker Positioning
Sinus Pause, Sinus Sick Syndrome
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

GEORGIOS LEVENTOPOULOS contact

+306977786020

levent2669@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Arrhythmia and Atrial Fibrillation (AF), run by University Hospital of Patras at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact GEORGIOS LEVENTOPOULOS (+306977786020, levent2669@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AHRE burden (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07305194, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.