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NCT Number: NCT07360067

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Location status: Recruiting

Location contact

Juwon Kim, MD

CONTACT

[email protected]

82+ 2-3410-3419

About this study

Previous studies have reported that conventional Right Atrial Appendage pacing is associated with delayed atrial activation time. A higher burden of atrial pacing at this site has been linked to an increased incidence of atrial fibrillation and atrial tachycardia. Furthermore, structural and functional deterioration of the atria-specifically Left Atrial dilation and reduced left atrial strain-has been observed in patients with a high percentage of Right Atrial Appendage pacing. These changes are known to accelerate the progression of atrial cardiomyopathy, potentially leading to adverse long-term clinical outcomes.

To address these limitations, Bachmann Bundle Pacing has emerged as a promising alternative pacing site. The Bachmann bundle is a major atrial myoarchitecture connecting the right and left atria. Pacing at this site is expected to facilitate interatrial conduction, thereby restoring interatrial synchrony and mitigating interatrial block. Prior research indicates that pacing at the Bachmann bundle is associated with a reduced incidence of atrial fibrillation and atrial tachycardia, suggesting distinct benefits regarding atrial electrophysiological outcomes. However, existing studies have primarily focused on electrophysiological parameters, such as arrhythmia incidence. Consequently, the impact of Bachmann Bundle Pacing on atrial structural and functional remodeling remains to be clearly elucidated.

Therefore, this study is designed as a single-center cohort study enrolling a total of 200 subjects (100 prospective and 100 retrospective). The investigators will analyze echocardiographic parameters over a 12-month period following pacemaker implantation. By comprehensively analyzing imaging parameters (left atrial/right atrial strain and volume changes assessed via echocardiography) and clinical outcomes (atrial arrhythmias, heart failure hospitalization, and mortality), this study aims to investigate the differential effects of Bachmann Bundle Pacing versus Right Atrial Appendage pacing on the development and progression of atrial cardiomyopathy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Right Atrial Appendage Pacing

Procedure

Atrial lead positioned in the right atrial appendage

Bachmann Bundle Pacing

Procedure

Atrial lead positioned in the bachmann bundle branch

Primary outcomes

  1. Structural echocardiographic parameters of the left atrium

    Time frame: 6 and 12 months after pacemaker implantation

    LA Volume Index measured as mL/m^2

  2. Functional echocardiographic parameters of the left atrium

    Time frame: 6 and 12 months after pacemaker implantation

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

Secondary outcomes

  1. Structural echocardiographic parameters of the left ventricle

    Time frame: 6 and 12 months after pacemaker implantation

    LV End-Diastolic Diameter(mm), LV End-Systolic Diameter(mm)

  2. Functional echocardiographic parameters of the left ventricle

    Time frame: 6 and 12 months after pacemaker implantation

    LV Ejection Fraction (%), Global Longitudinal Strain (%)

  3. Mitral and tricuspid regurgitation volume

    Time frame: 6 and 12 months after pacemaker implantation

    as mL per beat

  4. Structural echocardiographic parameters of the right atrium

    Time frame: 6 and 12 months after pacemaker implantation

    RA Volume Index (mL/m^2)

  5. Functional echocardiographic parameters of the right atrium

    Time frame: 6 and 12 months after pacemaker implantation

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

  6. ECG parameters

    Time frame: 6 and 12 months after pacemaker implantation

    PR interval (ms), QRS duration (ms), P wave duration (ms), QTC (ms)

  7. Average heart rate

    Time frame: 6 and 12 months after pacemaker implantation

    bpm

  8. Heart rate distribution

    Time frame: 6 and 12 months after pacemaker implantation

    percentage (%)

  9. Pacing burden

    Time frame: 6 and 12 months after pacemaker implantation

    percentage (%)

  10. Atrial fibrillation burden

    Time frame: 6 and 12 months after pacemaker implantation

    percentage (%)

  11. atrial fibrillation occurrence

    Time frame: 6 and 12 months after pacemaker implantation

    count

  12. NTproBNP

    Time frame: 6 and 12 months after pacemaker implantation

    pg/ml

  13. Procedure-related complications

    Time frame: 6 and 12 months after pacemaker implantation

    count

  14. Pacemaker/Implantable cardioverter defibrillator parameters

    Time frame: 6 and 12 months after pacemaker implantation

    Threshold (V)

  15. Pacemaker/Implantable cardioverter defibrillator parameters

    Time frame: 6 and 12 months after pacemaker implantation

    longevity (year)

  16. Cardiac mortality

    Time frame: 6 and 12 months after pacemaker implantation

    count

  17. All-cause mortality

    Time frame: 6 and 12 months after pacemaker implantation

    count

  18. Patient's functional status

    Time frame: 6 and 12 months after pacemaker implantation

    NYHA class I~IV

  19. hospitalization due to heart failure

    Time frame: 6 and 12 months post-procedure

    count

  20. re-admission due to any cause

    Time frame: 6 and 12 months post-procedure

    count

  21. Cerebrovascular event

    Time frame: 6 and 12 months post-procedure

    count

Study contacts

Contact information is provided by the study sponsor or research team.

Ju Hee Lee, Bachelor

CONTACT

[email protected]

82+ 10-7180-3357

Juwon Kim, MD

CONTACT

[email protected]

82+ 10-2079-8154

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Acronym: BRAVE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 22, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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