NCT06023784尚未招募不适用
The Impact of Left Bundle Branch Area Pacing Versus Right Ventricular Pacing on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- the incidence of new-onset atrial fibrillation
研究概览
简要总结
This is a single-center, randomized controlled study. The aim of this study is to compare the impact of left bundle branch area pacing versus traditional right ventricular pacing on the incidence of atrial fibrillation in patients with atrioventricular block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-85;
- •AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)> 40%, including (a) third-degree AV block; (b) second degree AV block (type II); (c) intermittent advanced AV block with expected VP>40%; (d) symptomatic first degree AV block and PR interval on ECG > 300ms;
- •Signed informed consent;
排除标准
- •Baseline echocardiographic assessment of patients with impaired LV function (LVEF<50%);
- •Patients with the history of atrial fibrillation;
- •Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;
- •Pacemaker replacement without new implanted ventricular electrodes;
- •Surgery is required within 1 year due to severe structural heart disease;
- •Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc);
- •AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM), (b) ventricular septal defect repair, and those who are unlikely to achieve successful LBBAP procedure.
结局指标
主要结局
the incidence of new-onset atrial fibrillation
时间窗: within two years after device implantation
次要结局
- an device upgrade for heart failure(within two years after device implantation)
- all-cause mortality(within two years after device implantation)
- alteration of quality of life score(within two years after device implantation)
- Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography(within two years after device implantation)
- pacemaker-associated cardiomyopathy(within two years after device implantation)
- hospitalization for heart failure(within two years after device implantation)
研究者
研究点 (1)
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