Samsung Medical Center
Seoul, 06351, South Korea
Location status: Recruiting
NCT Number: NCT07360067
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.
Interested in participating?
Request Info19 year and older
All sexes
Observational
Seoul, 06351, South Korea
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Atrial lead positioned in the right atrial appendage
Atrial lead positioned in the bachmann bundle branch
Time frame: 6 and 12 months after pacemaker implantation
LA Volume Index measured as mL/m^2
Time frame: 6 and 12 months after pacemaker implantation
Reservoir Strain (%), Conduit Strain (%), Contraction Strain (%)
Time frame: 6 and 12 months after pacemaker implantation
LV End-Diastolic Diameter(mm), LV End-Systolic Diameter(mm)
Time frame: 6 and 12 months after pacemaker implantation
LV Ejection Fraction (%), Global Longitudinal Strain (%)
Time frame: 6 and 12 months after pacemaker implantation
as mL per beat
Time frame: 6 and 12 months after pacemaker implantation
RA Volume Index (mL/m^2)
Time frame: 6 and 12 months after pacemaker implantation
RA Reservoir Strain (%), RA Conduit Strain (%), RA Contraction Strain (%)
Time frame: 6 and 12 months after pacemaker implantation
PR interval (ms), QRS duration (ms), P wave duration (ms), QTC (ms)
Time frame: 6 and 12 months after pacemaker implantation
bpm
Time frame: 6 and 12 months after pacemaker implantation
percentage (%)
Time frame: 6 and 12 months after pacemaker implantation
percentage (%)
Time frame: 6 and 12 months after pacemaker implantation
percentage (%)
Time frame: 6 and 12 months after pacemaker implantation
count
Time frame: 6 and 12 months after pacemaker implantation
pg/ml
Time frame: 6 and 12 months after pacemaker implantation
count
Time frame: 6 and 12 months after pacemaker implantation
Threshold (V)
Time frame: 6 and 12 months after pacemaker implantation
longevity (year)
Time frame: 6 and 12 months after pacemaker implantation
count
Time frame: 6 and 12 months after pacemaker implantation
count
Time frame: 6 and 12 months after pacemaker implantation
NYHA class I~IV
Time frame: 6 and 12 months post-procedure
count
Time frame: 6 and 12 months post-procedure
count
Time frame: 6 and 12 months post-procedure
count
Contact information is provided by the study sponsor or research team.
Ju Hee Lee, Bachelor
CONTACT
82+ 10-7180-3357
Juwon Kim, MD
CONTACT
82+ 10-2079-8154
Samsung Medical Center
Other
Acronym: BRAVE
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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