Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure ：A Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- ΔLVEF between baseline and six months post-discharge
研究概览
简要总结
This is a multicenter, randomized controlled study. This study aims to compare the clinical efficacy of LBBAP with traditional biventricular pacing in patients with permanent atrial fibrillation and heart Failure
详细描述
LBBAP-AFHF is a prospective, multicenter, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may show superiority of improved LV function as compared with traditional biventricular pacing (BiVP) in patients with permanent atrial fibrillation and heart failure (LVEF<50%) who receive atrioventricular nodal ablation due to fast ventricular rate or require high percentage of ventricular pacing due to slow ventricular rate. The primary endpoint of this trial is the change in the LVEF at 6 months after device implantation from baseline. A CRT-P/D device would be implanted and LBBAP lead would be connected to the RA port and LV lead to the LV port. Patients who receive successful LBBAP and BiVP simultaneously during the procedure would be 1:1 randomized to LBBAP or BiVP group after the procedure by device programming. Patients will be followed at 3 and 6 months post-discharge for LVEF and other echographic parameters (including LVESV, response rate), and rehospitalization for heart failure or all-cause death.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged more than 18 years old
- •Patients diagnosed with heart failure (LVEF<50%) and have received optimal medical therapy for at least 3 months
- •Patients with permanent atrial fibrillation (QRS duration <130ms) which need ventricular pacing, including:
- •LVEF<50%, NYHA II-IV, drug-refractory atrial fibrillation with the fast ventricular rate, planned atrioventricular nodal ablation due to 1). anticipated low success rate of atrial fibrillation catheter ablation or 2). patients refused to receive catheter ablation or 3). refused to receive another catheter ablation after a previous history of failed procedures
- •LVEF<50%, NYHA II-IV, atrial fibrillation with slow ventricular rate, anticipated ventricular pacing burden ≥ 40%
- •Written informed consent was provided
排除标准
- •expected survival time is less than 12 months
- •Prior history of mechanical tricuspid valve replacement and/or congenital heart disease (including dextrocardia, transposition of the great arteries, single left persistent left superior vena cava, etc.)
- •Plan for PCI or CABG due to unstable angina or myocardial infarction in 3 months
- •Surgery is required within 1 year due to severe structural heart disease
- •Pregnancy, planned pregnancy or heart transplant
- •Prior history of HCM and/or ventricular septal defect repair, who are unlikely to achieve successful LBBAP procedure.
- •Failure of lead placement due to abnormal anatomy of the coronary sinus or enlarged right atrium, which makes it unable to switch from one pacing modality to another
结局指标
主要结局
ΔLVEF between baseline and six months post-discharge
时间窗: Six months after device implantation
ΔLVEF：change in LVEF between baseline and six months after procedure
次要结局
- ΔLVEDV between baseline and six months post-discharge(6 months)
- The echocardiographic response rate of LVEF increase ≥5%(6 months)
- The changes of NT-proBNP betwen baseline and 6 months post-discharge(6 months)
- The rate of ΔLVESV ≥15% between baseline and six months post-discharge(6 months)
- ΔLVEDD between baseline and six months post-discharge(6 months)
- The echocardiographic response rate of LVEF increase ≥15%(6 months)
- The immediate success rate of the LBBAP procedure(1 weeks)
- The rate of procedure and Device related complications(6 months)
- Composite incidence rate of all-cause mortality and/or hospitalization for heart failure(6 months)
研究者
Xiaohan Fan
Professor, MD, PhD
Chinese Academy of Medical Sciences, Fuwai Hospital