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临床试验/NCT05557006
NCT05557006招募中不适用

Change of QRS Morphology and Electrophysiological Characteristics During Pacing Within the Interventricular Septum: a Prospective, Observational Study

General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Paced QRS morphology

研究概览

简要总结

Conduction system pacing (CSP), including His bundle pacing (HBP) and left bundle branch (LBB) pacing (LBBP), as a physiological pacing strategy, can achieve interventricular and/or intra-left ventricular mechanical synchronization by delivering physiological or nearly physiological ventricular activation. And many studies have verifed clinical efficacy of CSP that it can significantly relieve dyssynchrony of ventricular contraction, improve cardiac function and reduce the risk of heart failure as compared to right ventricular pacing. However, CSP has some shortcomings which limit its widespread application to some extent. As for HBP, although it can achieve optimal physiological ventricular synchronization, the problems of relatively high pacing threshold, low R-wave amplitude, the long-term performance, and inability to correct infra-Hisian atrioventricular block and intraventricular block in some patients have always been concerns. Nevertheless, LBBP is likely free of the restrictions mentioned above. On the contrary, LBBP can capture the left conduction system by directly stimulating the proximal LBB distal to the site of conduction block, thereby achieving rapid and physiological LV activation with a lower and stable pacing threshold and higher R-wave amplitude. However, as a newly emerged physiologic pacing technology, LBBP is currently in the exploratory stage and there are some phenomena to be interpreted, such as the evolution of pacing QRS morphology during the lead penetration into the interventricular septum. Therefore, the aim of this study is to assess the morphological evolution and electrophysiological characteristics of various pacing QRS patterns observed as the lead penetrates the interventricular septum from right to left.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • The indications for pacemaker implantation are in accordance with the 2021 European Society of Cardiology (ESC) guidelines.
  • Patients requiring a high percentage of ventricular pacing (>40% expected ventricular pacing) include patients with advanced or third-degree atrioventricular block and atrial fibrillation with bradycardia.
  • Left bundle branch pacing will be performed.
  • Patients voluntarily participate and sign informed consent.

排除标准

  • Atrioventricular block caused by reversible factors such as acute myocardial infarction and electrolyte disturbance.
  • Patients with severe liver or renal failure.
  • Life expectancy < 1 year.
  • Patients with age < 18 years.
  • Left ventricular ejection fraction (LVEF) < 40%.

结局指标

主要结局

Paced QRS morphology

时间窗: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.

Paced QRS morphology during lead penetration through the interventricular septum mainly includes left bundle branch block, intraventricular block and right bundle branch block.

Left ventricular activation time (LVAT)

时间窗: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.

Left ventricular activation time (LVAT) is defined as the interval from the onset of the pacing stimulus to the peak of the R wave in lead V5/6, which reflects the lateral precordial myocardium depolarization time.

Right ventricular activation time (RVAT)

时间窗: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.

Right ventricular activation time (RVAT) is defined as the interval from the onset of the pacing stimulus to the peak potential recorded by the atrial electrode temporarily placed in the right ventricle, which reflects delayed right ventricular activation.

次要结局

  • The late-R wave duration and amplitude in lead V1 (r´dur、r´amp)(Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.)
  • Stimulus-QRSend duration (s-QRSend)(Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.)
  • The S wave duration and amplitude in lead V6 (Sdur、Samp)(Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.)

研究者

发起方
General Hospital of Shenyang Military Region
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanchun Liang

Prof.

General Hospital of Shenyang Military Region

研究点 (1)

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