Efficacy and Safety Comparison of Lumenless Lead Versus Stylet-driven Lead in Intraoperative Application of Left Bundle Branch Pacing Guided by Continuous Pacing Monitoring With S-V Dissociation as the Primary Outcome: A Non-inferiority, Multicenter, Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint
研究概览
简要总结
Left Bundle Branch Pacing (LBBP) has emerged as one of the most commonly used physiological pacing modalities in clinical practice. However, the key determinants of procedural success lie in the accurate intraoperative identification of proper LBB lead positioning and the prevention of cardiac perforation. Our previous research has established a methodology for Lumenless Lead (LLL) implantation under the guidance of continuous pacing monitoring, and this methodology has been further adapted for Stylet-driven Lead (SDL) implantation. The present study is designed as a multicenter, randomized controlled trial, aiming to compare the differences in efficacy and safety between LLL and SDL during LBBP procedures guided by continuous pacing monitoring, with the presence of S-V dissociation serving as the criterion for confirming optimal LBB lead positioning.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic sick sinus syndrome (SSS);
- •Complete or advanced atrioventricular block (AVB);
- •Patients with heart failure complicated by left bundle branch block (LBBB) and biventricular dyssynchrony;
- •Patients with atrial fibrillation (AF) complicated by refractory rapid ventricular rate who are scheduled for atrioventricular node ablation and permanent pacemaker implantation;
- •Other patients who meet the indications for dual-chamber pacemaker implantation as specified in current guidelines
排除标准
- •Patients who are ineligible for transvenous cardiac pacemaker implantation due to anatomical abnormalities, infections, or other factors;
- •Patients with existing implantable cardiac electronic devices (ICEDs);
- •Patients who opt for right-sided venous access for any reason;
- •Patients with an expected survival of less than 1 year;
- •Patients who have been enrolled in other clinical trials related to implantable cardiac electronic devices within 3 months prior to enrollment in this study.
研究组 & 干预措施
SDL group
Subjects will receive implantation of a stylet-driven active fixation ventricular lead during the Left Bundle Branch Pacing (LBBP) procedure.
干预措施: SDL implantation (Procedure)
LLL group
Subjects will receive implantation of a lumenless active fixaion ventricular lead during the Left Bundle Branch Pacing (LBBP) procedure.
干预措施: LLL implantation (Procedure)
结局指标
主要结局
The primary efficacy endpoint
时间窗: During the LBBP procedure
The primary efficacy endpoint is defined as the success rate of intraoperative implantation of the left bundle branch lead with the documentation of S-V dissociation.
The primary safety endpoint
时间窗: From start of the procedure to the end of follow-up at 6 months
The primary safety endpoint is defined as a composite endpoint consisting of the following anticipated procedure-related serious adverse events (SAEs).
次要结局
- Procedural success rate(During the procedure.)
- Abnormal parameters detected during follow-up(From the start of procedure to the end of follow-up at 6 months)
- Assessment of cardiac function during follow-up(From the start of procedure to the end of follow-up at 6 months)
- Assessment of quality of life.(From the start of procedure to the end of follow-up at 6 months)