Intracardiac Electrical Characteristics of LBBAP
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Intracardiac electrical characteristics in different pacing outputs.
研究概览
简要总结
The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing (LBBAP), from which the findings may help to develop and support data validation of a novel algorithm for LBB capture determination for LBBAP.
详细描述
Among LBB area pacing (LBBAP), it has been reported that left ventricular (LV) septal pacing (LVSP), which refers to a pacing approach that only captures the LV septal myocardium, produces homogeneous electrical propagation in the septum and leads to delayed LV lateral wall activation. Although large randomized trials are lacking, small observational studies have shown more preserved physiological ventricular depolarization, or superior electrical and mechanical synchrony of the LBB capture over LVSP.
During the implantation of a device, the most commonly used method to distinguish LVSP from the LBB capture is to pace with different pacing outputs. A transition will be found in the ECG morphology with changes in the LV activation time if the pacing capture threshold (PCT) of the local myocardium is different from that of the LBB (i.e., LBB-PCT), indicating a transition between capturing the LBB and LVSP without any LBB capture. So far, there is no systematic investigation on the EGM characteristics or correlation between ECG and EGM characteristics at different conduction system capture status. Findings from this study will help to better characterize EGM characteristics and to develop an optimal LBBAP modality to differentiate LBB capture.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients who are willing to provide Informed Consent
- •Patients who have received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month)
- •Patients implanted with a single/dual-chamber pacemaker or a CRT-P with LBBAP lead connected to RV port
- •Implanted device can provide at least 3-channel real-time intracardiac electrogram
排除标准
- •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 clinical trial(s) which would impact study participation
结局指标
主要结局
Intracardiac electrical characteristics in different pacing outputs.
时间窗: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment
12-lead ECG and LBBAP EGM characteristics and duration in different pacing outputs.
次要结局
- The correlation between LBB capture status and LBBAP EGM characteristics(received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment)
- Intracardiac electrical characteristics under different body position.(received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment)