Electrocardiographic and Echocardiographic Characteristics of Bachmann's Bundle Area Pacing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Atrial-paced ECG P-wave duration at implantation and during regular follow-ups
研究概览
简要总结
This is a prospective, single-site, non-randomized, interventional study. The purpose is to collect electrocardiographic (ECG) and echocardiographic (echo) parameters and computed tomography (CT) images (optional) during Bachmann's bundle area pacing (BBAP) and conventional pacing in the right atrial appendage (RAA) to compare the differences between atrial pacing modalities and to further investigate the clinical outcomes of BBAP.
详细描述
Bachmann's bundle (BB) has emerged as an alternative pacing location to conventional right atrial appendage (RAA) pacing and is expected to avoid the interatrial conduction delay (IACD) and atrial dyssynchrony induced by RAA pacing. A recent study reported in patients with atrial pacing indications and baseline IACD that decreased atrial arrhythmia burden, recurrence, and de novo incidence were found in BB pacing, compared with right atrial septal pacing and RAA pacing. This study aimed to collect electrocardiographic (ECG) and echocardiographic (echo) parameters and CT images during BB area pacing (BBAP) and conventional pacing in the right atrial appendage (RAA) during regular pacemaker implantation procedures. The purpose is to compare the differences between atrial pacing modalities and to further investigate the clinical outcomes of BBAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >= 18 years old
- •Patients who are willing to provide Informed Consent
- •Patients who are indicated to atrial pacing, dual-chamber pacing, or cardiac resynchronization therapy
- •Patients who consent to Bachmann's bundle area pacing
排除标准
- •Patients who are indicated for cardiac implantable electronic device replacement or upgrade
- •Patients with defibrillation indications
- •Patients who are pregnant or have a plan for pregnancy during the study
- •Patients who have medical conditions that would limit study participation
- •Patients who were already enrolled in other trials which would impact his/her participation
研究组 & 干预措施
Single Arm - BBAP and RAA pacing
Bachmann's bundle area pacing (BBAP) and conventional pacing in the right atrial appendage during regular pacemaker implantation procedures are applied for acute electrocardiogram and echocardiogram testings. BBAP will be kept with remaining implantation procedure and followed-up at 3 months and/or 6 months.
干预措施: BBAP and RAA pacing (Procedure)
结局指标
主要结局
Atrial-paced ECG P-wave duration at implantation and during regular follow-ups
时间窗: From implantation to regular follow-ups up to 6 months
Atrial-paced ECG P-wave amplitude at implantation and during regular follow-ups
时间窗: From implantation to regular follow-ups up to 6 months
Atrial-paced P-onset to A-wave initiation time under Doppler at mitral and tricuspid valves at implantation
时间窗: Perioperative
次要结局
- LAD from echocardiographic measurements before implantation and during regular follow-ups(Baseline before implantation to regular follow-ups up to 6 months)