Prospective Cohort Study of Bachmann Bundle Versus Right Atrial Appendage Pacing: Impact on Atrial Cardiomyopathy Evaluated by Echocardiographic Parameters and Clinical Outcome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Structural echocardiographic parameters of the left atrium
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Right Atrial Appendage Pacing
Right Atrial Appendage Pacing
干预措施: Right Atrial Appendage Pacing (Procedure)
Bachmann Bundle Pacing
Bachmann Bundle Pacing
干预措施: Bachmann Bundle Pacing (Procedure)
结局指标
主要结局
Structural echocardiographic parameters of the left atrium
时间窗: 6 and 12 months after pacemaker implantation
LA Volume Index measured as mL/m\^2
Functional echocardiographic parameters of the left atrium
时间窗: 6 and 12 months after pacemaker implantation
Reservoir Strain (%), Conduit Strain (%), Contraction Strain (%)
次要结局
- 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)
- Atrial fibrillation burden(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)
- ECG parameters(6 and 12 months after pacemaker implantation)
- Average heart rate(6 and 12 months after pacemaker implantation)
- Heart rate distribution(6 and 12 months after pacemaker implantation)
- Pacing burden(6 and 12 months after pacemaker implantation)
- atrial fibrillation occurrence(6 and 12 months after pacemaker implantation)
- NTproBNP(6 and 12 months after pacemaker implantation)
- Procedure-related complications(6 and 12 months after pacemaker implantation)
- Pacemaker/Implantable cardioverter defibrillator parameters(6 and 12 months after pacemaker implantation)
- Cardiac mortality(6 and 12 months after pacemaker implantation)
- All-cause mortality(6 and 12 months after pacemaker implantation)
- Patient's functional status(6 and 12 months after pacemaker implantation)
- hospitalization due to heart failure(6 and 12 months post-procedure)
- re-admission due to any cause(6 and 12 months post-procedure)
- Cerebrovascular event(6 and 12 months post-procedure)