Prospective Cohort Study of Bachmann Bundle Versus Right Atrial Appendage Pacing: Impact on Atrial Cardiomyopathy Evaluated by Echocardiographic Parameters and Clinical Outcome

NCT07360067 | Recruiting

• 2 other identifiers: SMC2025-10-106KCT0011382
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the impact of different atrial pacing sites-Bachmann's bundle pacing versus right atrial appendage pacing-on the development and progression of atrial cardiomyopathy in patients diagnosed with sick sinus syndrome who are undergoing permanent pacemaker implantation.

Conditions

Sick Sinus Syndrome

Keywords

bachmann bundle pacing

Outcome Measures

Primary Outcomes (2)

• Structural echocardiographic parameters of the left atrium

  LA Volume Index measured as mL/m\^2

  6 and 12 months after pacemaker implantation

• Functional echocardiographic parameters of the left atrium

  Reservoir Strain (%), Conduit Strain (%), Contraction Strain (%)

  6 and 12 months after pacemaker implantation

Secondary Outcomes (21)

• Structural echocardiographic parameters of the left ventricle

  6 and 12 months after pacemaker implantation

• Functional echocardiographic parameters of the left ventricle

  6 and 12 months after pacemaker implantation

• Mitral and tricuspid regurgitation volume

  6 and 12 months after pacemaker implantation

• Structural echocardiographic parameters of the right atrium

  6 and 12 months after pacemaker implantation

• Functional echocardiographic parameters of the right atrium

  6 and 12 months after pacemaker implantation

Study Arms (2)

Right Atrial Appendage Pacing

Right Atrial Appendage Pacing

Procedure: Right Atrial Appendage Pacing

Bachmann Bundle Pacing

Bachmann Bundle Pacing

Procedure: Bachmann Bundle Pacing

Interventions

Right Atrial Appendage Pacing PROCEDURE

Atrial lead positioned in the right atrial appendage

Right Atrial Appendage Pacing

Bachmann Bundle Pacing PROCEDURE

Atrial lead positioned in the bachmann bundle branch

Bachmann Bundle Pacing

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who presented to Samsung Medical Center, were diagnosed with Sick Sinus Syndrome, and underwent de novo permanent pacemaker or implantable cardioverter-defibrillator implantation based on clinical indications.

You may qualify if:

• Patients aged 19 years or older
• Patients diagnosed with sick sinus syndrome who are scheduled for de novo implantation of a permanent pacemaker or permanent implantable cardioverter-defibrillator
• Patients or their legal representatives who voluntarily consent to the access of medical records and study data throughout the entire research period

You may not qualify if:

• Patients with persistent or permanent AF
• Patients with a life expectancy of less than one year due to other comorbidities
• Pregnant or breastfeeding women
• Patients who refuse active treatment

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

RECRUITING

Related Publications (10)

• 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

• 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

• Lustgarten DL, Habel N, Sanchez-Quintana D, Winget J, Correa de Sa D, Lobel R, Thompson N, Infeld M, Meyer M. Bachmann bundle pacing. Heart Rhythm. 2024 Sep;21(9):1711-1717. doi: 10.1016/j.hrthm.2024.03.1786. Epub 2024 Mar 27. No abstract available.

  PMID: 38552731 RESULT

• Martens P, Deferm S, Bertrand PB, Verbrugge FH, Ramaekers J, Verhaert D, Dupont M, Vandervoort PM, Mullens W. The Detrimental Effect of RA Pacing on LA Function and Clinical Outcome in Cardiac Resynchronization Therapy. JACC Cardiovasc Imaging. 2020 Apr;13(4):895-906. doi: 10.1016/j.jcmg.2019.04.022. Epub 2019 Jul 17.

  PMID: 31326478 RESULT

• Roithinger FX, Abou-Harb M, Pachinger O, Hintringer F. The effect of the atrial pacing site on the total atrial activation time. Pacing Clin Electrophysiol. 2001 Mar;24(3):316-22. doi: 10.1046/j.1460-9592.2001.00316.x.

  PMID: 11310300 RESULT

• De Sisti A, Leclercq JF, Stiubei M, Fiorello P, Halimi F, Attuel P. P wave duration and morphology predict atrial fibrillation recurrence in patients with sinus node dysfunction and atrial-based pacemaker. Pacing Clin Electrophysiol. 2002 Nov;25(11):1546-54. doi: 10.1046/j.1460-9592.2002.01546.x.

  PMID: 12494610 RESULT

• Elkayam LU, Koehler JL, Sheldon TJ, Glotzer TV, Rosenthal LS, Lamas GA. The influence of atrial and ventricular pacing on the incidence of atrial fibrillation: a meta-analysis. Pacing Clin Electrophysiol. 2011 Dec;34(12):1593-9. doi: 10.1111/j.1540-8159.2011.03192.x. Epub 2011 Aug 7.

  PMID: 21819434 RESULT

• Bradshaw PJ, Stobie P, Knuiman MW, Briffa TG, Hobbs MS. Trends in the incidence and prevalence of cardiac pacemaker insertions in an ageing population. Open Heart. 2014 Dec 10;1(1):e000177. doi: 10.1136/openhrt-2014-000177. eCollection 2014.

  PMID: 25512875 RESULT

• Honarbakhsh S, Hunter L, Chow A, Hunter RJ. Bradyarrhythmias and pacemakers. BMJ. 2018 Mar 15;360:k642. doi: 10.1136/bmj.k642. No abstract available.

  PMID: 29545242 RESULT

• Kusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, Goldschlager NF, Hamilton RM, Joglar JA, Kim RJ, Lee R, Marine JE, McLeod CJ, Oken KR, Patton KK, Pellegrini CN, Selzman KA, Thompson A, Varosy PD. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2019 Aug 20;140(8):e382-e482. doi: 10.1161/CIR.0000000000000628. Epub 2018 Nov 6. No abstract available.

  PMID: 30586772 RESULT

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kim Ju Won, Clinical assistant professor, Ph.D

CONTACT

82+ 10-2079-8154; abcd186a@naver.com

Lee Ju Hee, Clinical Research Nurse, Bachelor

CONTACT

82+ 10-7180-3357; phacyde12@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

KR (1)