ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Left ventricular resynchronization assessed by ECGI
研究概览
简要总结
The goal is to validate the resynchronization criteria with a non-invasive technique, during the LBBP implant. Non-invasive real-time ventricular activation maps will be created and analyzed before, during, and after the implantation of the left bundle branch lead, including right septal pacing, mid and deep septal pacing and pacing when reaching the left bundle branch according to the published standard LBBP criteria. Using these maps, the investigators will quantify activation times and evaluate changes in the ventricular sequence during implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left bundle branch pacing indication
- •Capability of standing up to place the ECGI vest
排除标准
- •Less than 18 years-old
- •Patients with cognitive impairment
研究组 & 干预措施
Left Bundle Branch electrode implant
干预措施: ECGI system during LBBP implant (Device)
结局指标
主要结局
Left ventricular resynchronization assessed by ECGI
时间窗: During procedure
Resynchronization assesed by non-invasive ECGI by the Left Ventricle Activation Time reduction and the septal activation ventricular pattern once reaching the LBBP according to the published ECG criteria.
次要结局
- LVDI(During procedure)
- VEU(During procedure)
- LVAT(During procedure)
- Isochronal Crowding(During procedure)
- Histogram Overlap(During procedure)
研究者
Josep Lluis Mont Girbau
Arrhythmia Section MD PhD
Hospital Clinic of Barcelona