Electrogram and Hemodynamic Characteristics of Adaptive LBBAP in Patients With Heart Failure or Bradycardia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- ECG QRS duration
研究概览
简要总结
This is a multi-site, non-randomized, data collection study. The purpose of this study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.
详细描述
Left bundle branch pacing (LBBP), achieved via trans-septal approach with the pacing tip at the left side of the ventricular septum, has recently initiated and been well practiced in China. LBBP is characterized with relatively ease of implantation (usually <5 minutes fluoroscopic use time), narrow paced QRS duration (similar to physiological pacing), low and stable pacing threshold (usually around 0.5V @0.5ms, good for device longevity and long-term stability without need of back-up pacing lead), high R wave amplitude for pacing management, and LBBB (left bundle branch block) correction by a low pacing output.
LBBAP (left bundle branch area pacing) can generate a relatively narrow QRSd and fast left ventricular activation. As AV interval is an important pacing parameter relevant to cardiac function. This study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 18 to 80 years old
- •Patients who are willing to provide Informed Consent
- •Patients who received LBBAP for at least 3 months
- •Patients' implanted device can provide intracardiac electrograms
- •Bradycardia patients with AVB or heart failure patients with LBBB
排除标准
- •Patients who are pregnant or have a plan for pregnancy during the study
- •Patients with persistent AF
- •Patients who have medical conditions that would limit study participation
- •Patients who were already enrolled in other clinical trial which would impact his/her participation
结局指标
主要结局
ECG QRS duration
时间窗: At least 3 months post implant
The primary endpoint is QRS duration during LBBP
次要结局
未报告次要终点