跳至主要内容
临床试验/NCT05817695
NCT05817695招募中不适用

Effect of Different Pacing Sites on Cardiac Synchronization and Tricuspid Regurgitation After Leadless Pacemaker Implantation

First People's Hospital of Hangzhou1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年3月1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
40
试验地点
1
主要终点
The evaluation of cardiac electrical synchrony

研究概览

简要总结

Comparison of cardiac synchronization and tricuspid regurgitation with or without leadless pacemaker pacing in different site

详细描述

Right ventricular pacing might lead to pacing-induced cardiomyopathy by dyssynchrony and tricuspid regurgitation. Pacing at various sites had different effects on synchrony and tricuspid regurgitation. This study is to observe the effect of leadless pacemaker implantation in different regions on ventricular synchronization and tricuspid regurgitation. Ultrasound and ECG parameter indices are applied.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •patients consent to LP implantation surgery

排除标准

  • •Patients with inferior vena cava thrombus, a cancer thrombus, an abnormal inferior vena cava;
  • •Patients with femoral vein stenosis and tortuosity failed to accommodate the pacemaker delivery system;
  • •Patients with myocardial infarction;
  • •Patients who have been implanted with devices that affect the pacemaker delivery system, such as vena cava filters or tricuspid valve mechanical valves;
  • •cannot understand or are unwilling to give informed consent.

结局指标

主要结局

The evaluation of cardiac electrical synchrony

时间窗: 1 month

the QRS duration after pacing

The evaluation of cardiac mechanical synchrony

时间窗: 1 month

①Synchronization analysis between left and right ventricles: interventricular mechanical delay (IVMD) in millisecond. ②Left ventricle synchrony analysis: septal-to-posterior wall motion delay (SPWMD) in millisecond,left pre-ejection interval(LPEI) in millisecond.

次要结局

  • The pacemaker sensing may affect synchronization(1 month)
  • BMI may affect synchronization(1 month)
  • Blood pressure may affect synchronization(1 month)
  • Age may affect synchronization(1 month)
  • The pacemaker lead impedance may affect synchronization(1 month)

研究者

发起方
First People's Hospital of Hangzhou
申办方类型
Other
责任方
Sponsor

研究点 (1)

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