Prospective Multicenter Randomized Controlled Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 266
- 试验地点
- 12
- 主要终点
- number of cardiovascular deaths
研究概览
简要总结
Transcatheter aortic valve implantation (TAVI) has rapidly expanded over the past decade as a treatment for severe aortic valve stenosis, with over 14,000 procedures performed in France in 2021. A common complication following TAVI is traumatic atrioventricular block requiring pacemaker implantation, occurring in about 10% of patients. Conventional right ventricular pacing in these cases often leads to interventricular dyssynchrony, which can impair left ventricular ejection fraction and increase the risk of hospitalization, heart failure, and mortality.
Cardiac resynchronization therapy via biventricular pacing is sometimes proposed as a secondary intervention but involves additional surgery. A newer pacing technique-selective left bundle branch area pacing-has been developed to provide physiological ventricular activation by stimulating conduction pathways distal to the lesion, thereby avoiding dyssynchrony. Retrospective studies suggest clinical benefits, but no prospective randomized trial has yet evaluated its efficacy compared to standard pacing.
The objective of this study is to conduct the first randomized clinical trial comparing left bundle branch area pacing versus conventional right ventricular pacing in patients requiring pacemaker implantation due to atrioventricular block after TAVI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Patients who have undergone TAVI for severe aortic valve disease within the past 3 months
- •Preserved left ventricular ejection fraction (LVEF ≥ 50%)
- •Indications for pacemaker implantation according to guidelines, including :
- •Third-degree atrioventricular (AV) block
- •Second-degree AV block Mobitz type 2 or symptomatic Mobitz type 1
- •Alternating left and right bundle branch block
- •HV interval ≥ 70 ms during electrophysiological study
- •Pre-existing right bundle branch block with worsening conduction disturbances post-TAVI
- •Prolongation of QRS and PR intervals post-procedure justifying pacemaker implantation
- •Signed informed consent
- •Patient affiliated with the national health insurance system
排除标准
- •Left ventricular ejection fraction (LVEF) < 50% before TAVI
- •Contraindication to implantation of an endocardial pacemaker (vascular access issues, sepsis)
- •Previously implanted pacemaker
- •Patients under legal guardianship, curatorship, or judicial protection
- •Participation in another interventional therapeutic clinical trial
研究组 & 干预措施
LBAP : Left Bundle Area Pacing
Pacemaker implantation using left bundle branch area stimulation
干预措施: Pacemaker implantation using left bundle branch area stimulation (Procedure)
RVP : Right Ventricular Pacing
Right ventricular pacemaker implantation
干预措施: Right ventricular pacemaker implantation (Procedure)
结局指标
主要结局
number of cardiovascular deaths
时间窗: 24 months
number of hospitalizations for heart failure
时间窗: 24 months
number of surgical reinterventions
时间窗: 24 months
次要结局
- success rate of the LBAP technique(3, 12, and 24 months post-implantation)
- comparison of immediate and long-term complications of the LBAP stimulation(3, 12, and 24 months post-implantation)
- ECG measurements(3, 12, and 24 months post-implantation)
- left ventricular function (LVEF)(3, 12, and 24 months post-implantation)
- left ventricular diameter(3, 12, and 24 months post-implantation)
- creatinine levels(3, 12, and 24 months post-implantation)
- GFR in CKD EPI(3, 12, and 24 months post-implantation)
- Comparison of the occurrence of atrial fibrillation and ventricular tachycardia (non-sustained or sustained), based on pacemaker monitoring data.(3, 12, and 24 months post-implantation)
- EQ-5D-5L questionnaire.(Baseline (inclusion), 3, 12, and 24 months post-treatment)
- Evaluate the cost-effectiveness of left bundle branch area pacing versus standard therapy in this population using a cost-utility analysis.(24 months post-implantation)