Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Incidence of loss of left bundle branch capture
研究概览
简要总结
This trial seeks to evaluate the performance of the extendable helix, stylet-driven pacing lead (SDL) compared to the fixed helix, lumenless pacing lead (LLL) during left bundle branch pacing (LBBP), with respect to enduring left bundle branch capture on follow-up, incidence of acute lead failure, pacing characteristics including QRS duration, pacing thresholds, R-wave amplitudes and lead impedance, and finally, safety profile during LBBP implantation. These data will guide future lead selection during LBBP implantation in achieving improved procedural success and optimal lead performance.
详细描述
This study is a single-blind, randomised controlled trial, aimed at evaluating the performance of the extendable helix, stylet driven pacing lead (SDL) compared to the fixed helix, lumenless pacing lead (LLL) during left bundle branch pacing (LBBP). The study is a multicentre study across 3 major hospitals in Singapore, and LBBP performed by independent electrophysiologists experienced in performing LBBP.
The primary objective of the study is to determine differences in incidence of loss of left bundle capture by pacing lead design (LLL vs SDL). The secondary objectives are to determine if lead design affects frequency of lead failure during implantation, investigate differences in short- and medium-term LBBP parameters on follow-up by lead design, and evaluate differences in safety profile between LLL and SDL in LBBP.
This study aims to recruit a target of 210 patients. A previous retrospective study found a loss of LB capture rate of 9% with LLL and 25% with SDL. A sample size of 170 will be required for a type-1 error rate of 5% and power of 80%. Accounting for a dropout rate of 20%, a total of 210 patients will be recruited (105 per group). Eligible subjects will be randomised to either the LLL or the SDL arm. The randomisation list will be generated with a computer-generated sequence in permuted blocks of 4, stratified by centre, to ensure a final allocation ratio of 1:1.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Subjects will be blinded to the type of pacing lead received. Operators will not be blinded as they will be performing the procedure. Post-procedure, investigators and outcomes assessors will be blinded to the treatment arm during adjudication of outcomes.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fulfil current indications for pacemaker therapy according to international guideline recommendations:
- •Symptomatic sinus bradycardia/sinus node dysfunction or AV block requiring pacemaker insertion.
- •Symptomatic heart failure, left ventricular ejection fraction (LVEF) <35%, left bundle branch block and QRS duration >120ms.
- •Symptomatic heart failure, left ventricular ejection fraction (LVEF) <35%, right bundle branch block and QRS duration >150ms.
- •LVEF <50% with significant anticipated ventricular pacing requirement of ≥20%.
- •Age ≥21 years old
- •Able to provide informed consent
- •Planned LBBP implantation
排除标准
- •Severe tricuspid regurgitation or previous tricuspid valve intervention requiring implantation of left ventricular lead in the coronary sinus.
- •Unable to provide informed consent.
- •Pregnant women.
- •<21 years of age.
结局指标
主要结局
Incidence of loss of left bundle branch capture
时间窗: 12 months
Loss of LBB capture is defined as the absence of the terminal r/R' complex in V1 during initial threshold interrogations at high pacing outputs and the absence of transitions in paced QRS morphology with decreasing pacing outputs until loss of myocardial capture.
次要结局
- Serial changes in R-wave amplitude (mV)(12 months)
- Serial changes in lead impedance (ohm)(12 months)
- Serial changes in QRS duration (ms)(12 months)
- Incidence of acute lead failure(12 months)
- Incidence of peri-procedural complications(12 months)
- Serial changes in pacing thresholds (V)(12 months)