Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Heart failure hospitalization
研究概览
简要总结
Permanent ventricular pacing may be complicated with ventricular dyssynchrony and subsequent pacing-induced cardiomyopathy. We hypothesized that left bundle branch area pacing may prevent the development of pacing-induced cardiomyopathy in patients with permanent atrial fibrillation requiring permanent ventricular pacing.
Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.
They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation.
They will be prospectively followed during 6 months.
详细描述
Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.
They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing confirmed according to electrocardiographic parameters. Atrioventricular node ablation will be performed the following day through a femoral venous approach.
Perioperative data and potential complications will be collected. Patients will be prospectively followed during 6 months. They will have clinical examination, 12-lead ECG, and an echocardiography.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Permanent atrial arrhythmia
- •Symptoms related to an insufficient rate control under optimal medical therapy
排除标准
- •Indication of prophylactic defibrillator
- •Already implanted with a cardiac device
结局指标
主要结局
Heart failure hospitalization
时间窗: 6 months
Hospitalization for decompensated heart failure
次要结局
- Complications(30 days)
- Mortality(6 months)
- Electrical remodeling(6 months)
- Volumetric response(6 months)
研究者
Nicolas Clementy, MD, PhD
Associate Professor
University Hospital, Tours