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

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Samsung Medical Center

Status

Enrolling

Conditions

Sick Sinus Syndrome

Treatments

Procedure: Bachmann Bundle Pacing
Procedure: Right Atrial Appendage Pacing

Study type

Observational

Funder types

Other

Identifiers

NCT07360067
KCT0011382 (Other Identifier)
SMC2025-10-106

Details and patient eligibility

About

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.

Full description

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). We 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.

Enrollment

200 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Right Atrial Appendage Pacing
Description:
Right Atrial Appendage Pacing
Treatment:
Procedure: Right Atrial Appendage Pacing
Bachmann Bundle Pacing
Description:
Bachmann Bundle Pacing
Treatment:
Procedure: Bachmann Bundle Pacing

Trial contacts and locations

1

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Central trial contact

Kim Ju Won, Clinical assistant professor, Ph.D; Lee Ju Hee, Clinical Research Nurse, Bachelor

Data sourced from clinicaltrials.gov

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