NCT04505384已完成不适用
Acute Effects of Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Hemodynamic parameter LV dP/dt(max)
研究概览
简要总结
The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) <=35% with left bundle branch block (LBBB).
详细描述
The metrics include electrocardiographic, echocardiographic and hemodynamic parameters to evaluate and compare LBBP with BVP for resynchronization therapy in patients with heart failure and LBBB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •NYHA class II-IV;
- •LVEF <=35%;
- •LBBB with QRS duration >=130ms.
排除标准
- •moderate-to-severe aortic stenosis;
- •frequent premature ventricular complexes;
- •significant peripheral vascular disease.
结局指标
主要结局
Hemodynamic parameter LV dP/dt(max)
时间窗: 1 hour
LV dP/dt(max) will be obtained during implant procedure.
次要结局
- Mechanical parameters including Ts-SD and IVMD(0.5 hour)
- Electrical synchrony parameters including QRS duration and QRS area(0.5 hour)
研究者
研究点 (1)
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