跳至主要内容
临床试验/NCT05401851
NCT05401851招募中不适用

Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study

Universitair Ziekenhuis Brussel2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Epicardial map

研究概览

简要总结

Study of the ventricular activation patterns during left bundle area pacing and compare it with baseline activation during normal sinus rhythm in patients with and without baseline bundle branch conduction disorder.

详细描述

Right ventricular (RV) pacing has long been the gold standard treatment for symptomatic brady arrhythmias. Right ventricular apical pacing has shown to cause electrical and mechanical desynchrony resulting in left ventricular (LV) dysfunction, and, in some cases, clinical heart failure together with other mechanical and arrhythmic complications. Hence, it was necessary to find a more physiologic method of pacing that ensures synchrony. His bundle pacing was first described in 2000, and is more recently adapted as a pacing method with less deleterious effects on the RV. However, lead dislodgement, high pacing thresholds, battery depletion, and difficulty identifying the exact location of His bundle were the most significant concerns related to this method. Subsequently, left bundle branch area pacing (LBB-AP), first described in 2017 by Huang et al, has emerged as safe alternative with excellent lead stability and capture threshold, and more ability to correct distal conduction disease as compared to His bundle pacing. Recent studies report promising mid-term outcome concerning left ventricular desynchrony. To the best of our knowledge, bi-ventricular activation was never studied in patients with LBB-AP.

Multiple tools have been used to assess biventricular (BiV) synchrony specially with chronic resynchronization therapy (CRT) including echocardiography and 12 lead ECG. Eschalier et al. found that epicardial noninvasive ECG mapping, was better at predicting clinical CRT response than QRS duration or the presence of LBBB. Activation patterns and timings with RV apical pacing, native LBBB, and BiV pacing have been well studied using this tool. With LBBP, however, these activation parameters have not yet been described.

This study aims to evaluate bi-ventricular activation in patients equipped with LBB-AP using non-invasive 3D mapping system in patients with or without baseline ventricular conduction disorder.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • 30 patients with a functional LBB-AP pacemaker

排除标准

  • Age < 18 years
  • Previous cardiac surgery
  • Cardiomyopathy with documented ventricular scar
  • Patients with prior pacemaker

研究组 & 干预措施

Body surface mapping

Other

With the Insite Vest, activation of the epicardium will be performed.

干预措施: Left Bundel Area Pacing (Device)

结局指标

主要结局

Epicardial map

时间窗: 1 day

Activation patterns (visual inspection) on non-invasive 3D ECG mapping

次要结局

  • Echo parameters for resynchronization(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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