Clinical Study on the Application of Two-dimensional Speckle Tracking Imaging to Evaluate the Atrial Synchrony of Bachmann Bundle Pacing in Patients With Sick Sinus Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Inter-atrial Electromechanical Delay (Inter AEMD)
研究概览
简要总结
This is a prospective, randomized study to compare the effects of Bachmann bundle pacing (BBP) versus conventional right atrial appendage (RAA) pacing on atrial electromechanical synchrony in patients with sick sinus syndrome (SSS). The study utilizes two-dimensional speckle tracking imaging (2D-STI) to assess improvements in cardiac function and synchrony, aiming to determine a more optimal pacing site for SSS patients.
详细描述
Sick sinus syndrome (SSS) is a common indication for permanent pacemaker implantation. Conventional right atrial appendage (RAA) pacing, however, is non-physiological and may lead to atrial conduction delays, atrial remodeling, and an increased risk of atrial fibrillation. Bachmann bundle pacing (BBP) is emerging as a more physiological pacing strategy that may correct atrial conduction delays and improve electromechanical synchronization. This study prospectively enrolled and randomized 72 patients with SSS to receive either BBP or RAA pacing. The primary objective is to evaluate the differences in atrial synchrony, cardiac function, and pacing parameters between the two groups at baseline, 1-month, and 3-month follow-ups, using electrocardiography and two-dimensional speckle tracking imaging (2D-STI). The study aims to provide evidence for BBP as a superior treatment option for improving long-term outcomes in SSS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets diagnostic criteria for sick sinus syndrome (e.g., persistent sinus bradycardia <50 bpm, sinus arrest, sinoatrial block, or tachy-brady syndrome).
- •Age between 30 and 90 years.
- •Has not taken any other antiarrhythmic drugs within one month prior to enrollment.
- •Has not participated in any other related clinical trials.
- •Voluntarily signs the informed consent form.
排除标准
- •Patients with severe primary diseases causing unstable vital signs (e.g., severe circulatory, digestive, or neurological system diseases).
- •Patients with a history of recurrent syncope, Adams-Stokes syndrome, severe bradycardia (lowest sinus rhythm <30 bpm), or long RR interval >3s.
- •Pregnant or lactating women.
- •Patients with mental illness.
结局指标
主要结局
Change in Inter-atrial Electromechanical Delay (Inter AEMD)
时间窗: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Measured by two-dimensional speckle tracking imaging (2D-STI) as the time difference between the onset of the P-wave on the electrocardiogram (ECG) and the peak longitudinal strain of the lateral walls of the right and left atria. A smaller value indicates better inter-atrial synchrony.
Change in Intra-atrial Mechanical Delay (IAMD)
时间窗: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Measured by 2D-STI as the standard deviation of the time-to-peak longitudinal strain of six segments of the left atrium. A smaller value indicates better intra-atrial synchrony.
Change in Intra-right Atrial Electromechanical Delay (Intra-right AEMD)
时间窗: Baseline, 1 Month Post-procedure, 3 Months Post-procedure
Measured by 2D-STI as the time difference between the earliest and latest peak longitudinal strain within the right atrium segments.
次要结局
- Change in P-wave Duration (PWD) and Morphology(Baseline, 1 Month Post-procedure, 3 Months Post-procedure)
- Change in QRS Duration and Axis(Baseline, 1 Month Post-procedure, 3 Months Post-procedure)
- Change in Left Atrial (LA) and Right Atrial (RA) Dimensions(Baseline, 1 Month Post-procedure, 3 Months Post-procedure)
- Change in Left Ventricular End-Systolic Diameter (LVESD) and End-Diastolic Diameter (LVEDD)(Baseline, 1 Month Post-procedure, 3 Months Post-procedure)
- Change in Left Atrial Strain Parameters(Baseline, 1 Month Post-procedure, 3 Months Post-procedure)
- Change in Atrial Sensing (P-wave amplitude)(1 Month Post-procedure, 3 Months Post-procedure)
- Change in Atrial Pacing Impedance(1 Month Post-procedure, 3 Months Post-procedure)
- Recurrence of Atrial Arrhythmia(Up to 1 year)
- Change in Ventricular Pacing Threshold(1 Month Post-procedure, 3 Months Post-procedure)
- Change in Ventricular Sensing (R-wave amplitude)(1 Month Post-procedure, 3 Months Post-procedure)
- Percentage of Ventricular Pacing(1 Month Post-procedure, 3 Months Post-procedure)
- Change in Atrial Pacing Threshold(1 Month Post-procedure, 3 Months Post-procedure)
- Change in Ventricular Pacing Impedance(1 Month Post-procedure, 3 Months Post-procedure)
研究者
You Wu
Principal Investigator
Beijing Anzhen Hospital