Feasibility of Simplified Permanent Left Bundle Branch Pacing (LBBP) Without Electrophysiological Recording System
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Judgment coincidence rate
研究概览
简要总结
This is a prospective, single-center study of patients with an indication for ventricular pacing who attempted LBBP without electrophysiology recording system (EP system).
详细描述
Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, the implanter was blinded to EP system, only refer to ECG monitoring. The transition of QRS morphology from S-LBBP (or LVSP) to NS-LBBP, abrupt shortening of Stim-LVAT in lead V5, combined with LV septal-derived PVCs and obvious LBB potential in pacing system analyzer were recorded to help the implanter confirm LBB capture. Meanwhile, the technician recorded the data by EP system and evaluated the consistency of the judgment. The primary endpoints included the success rate, procedure-related information, parameters and complications during 3-month follow-up.
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
- •(1) requiring ventricular pacing; (2) older than 18 years; (3) signed informed consent.
排除标准
- •(1) acute anterior myocardial infarction; (2) intraventricular conduction delay (IVCD); (3) ventricular septal hypertrophy (end-diastolic thickness over 15 mm).
研究组 & 干预措施
No EP system Group
Patients were performed left bundle branch pacing without EP system.
干预措施: Left bundle branch pacing (Device)
结局指标
主要结局
Judgment coincidence rate
时间窗: Intraoperative
Coincidence rate between the judgment made by the operator through ECG and PSA with EP system.
Successful rate
时间窗: Immediate Postoperative
Success rate of left bundle branch pacing without EP system
Intraoperative complications
时间窗: Immediate Postoperative
Intraoperative complications were recorded
Postoperative complications
时间窗: 3 months
Postoperative complications were recorded
次要结局
- Change of impedance(Ω) from immediate postoperative(3 months)
- Fluoroscopy time(Immediate Postoperative)
- Change of threshold(V/0.5ms) from immediate postoperative(3 months)
- Procedure duration(Immediate Postoperative)
- Change of LVEF(%) from baseline(3 months)