跳至主要内容
临床试验/NCT05722379
NCT05722379招募中不适用

Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block: an Observational Cohort Study

West China Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups

研究概览

简要总结

Although emerging evidence demonstrated that left bundle branch pacing (LBBP) is a promising alternative for patients with either a bradycardia or a heart failure pacing indication. However, a direct comparison of the safety, efficacy and LV systolic synchrony between LBBP and RVP regimens was rare. In this study, the investigators aim to conduct a comparison of the safety and effectiveness performance between these two pacing methods for patients with atrioventricular block (AVB). The investigators focused on AVB patients undergoing permanent pacemaker implantations from the 1st of January 2018 to the 18th of November 2021 at West China Hospital.

详细描述

Right ventricular pacing (RVP) is the standard treatment for patients with continuous ventricular pacing needs. However, clinical studies have shown that RVP can cause electrical and mechanical dyssynchrony of the left ventricle and increase the risks of cardiac insufficiency, atrial fibrillation (AF) and death. Although emerging evidence demonstrated that left bundle branch pacing (LBBP) is a promising alternative for patients with either a bradycardia or a heart failure pacing indication. However, a direct comparison of the safety, efficacy and LV systolic synchrony between LBBP and RVP regimens was rare. In this study, the investigators aim to conduct a comparison of the safety and effectiveness performance between these two pacing methods for patients with atrioventricular block (AVB). The investigators focused on AVB patients undergoing permanent pacemaker implantations from the 1st of January 2018 to the 18th of November 2021 at West China Hospital.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • included consecutively high-grade AVB patients undergoing permanent pacemaker implantations from the 1 s t of January 2018 to the 18 thof November 2021 at West China Hospital

排除标准

  • patients with pacemaker replacements were excluded.

结局指标

主要结局

composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups

时间窗: through study completion, an average of 2.45 year

composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups

Lead failure

时间窗: through study completion, an average of 2.45 year

reintervention for increased pacing thresholds, lead dislocation or ventricular perforation after the initial implantation procedure

HFH

时间窗: through study completion, an average of 2.45 year

HFH was defined as the admission to hospital for \>24 hours with worsening symptoms and signs of heart failure and requiring one or more intravenous diuretics or intravenous inotropic medications

次要结局

  • peri-procedure complication(through study completion, an average of 2.45 year)
  • cardiac death(through study completion, an average of 2.45 year)
  • recurrent unexplained syncope(through study completion, an average of 2.45 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhongxiu Chen

Dr, cardiology department, principal investigator

West China Hospital

研究点 (1)

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