跳至主要内容
临床试验/NCT04115735
NCT04115735终止不适用

Obtaining His Bundle Recording From the Subclavian Vein in Patients Undergoing Permanent Pacemaker Implantation

TriHealth Inc.1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
Successful recording of a His bundle potential

研究概览

简要总结

His bundle pacing has been proposed as a superior alternative to standard right ventricular pacing. The purpose of this study is to investigate whether obtaining a His Bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath can be done in a quick and reliable manner. This would support the use of stylet driven leads for His bundle pacing.

详细描述

The purpose of this prospective observational study is to investigate whether obtaining a His Bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath can be done in a quick and reliable manner. Included in the study are patients undergoing permanent pacemaker implantation at Good Samaritan and Bethesda North Hospitals. The main outcome is successful recording of a His bundle potential. Secondary outcomes are the time necessary to record the His bundle and the measurement of the pacing threshold.

研究设计

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

入排标准

年龄范围
18 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years Male or Female Patients undergoing HIS bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath

排除标准

  • Patients who are unwilling or unable to sign the informed consent Pregnant women

结局指标

主要结局

Successful recording of a His bundle potential

时间窗: From beginning of procedure to the end

The pacing lead will be connected to a standard EP recording system (GE CardioLab, LS Pro, or EP Med) a copy of the intracardiac electrograms demonstrating His bundle recording will be saved electronically.

次要结局

  • Time necessary to record the HIS bundle(From insertion of the pacing lead until successful measurement of HIS bundle)
  • Pacing threshold(From beginning of procedure to the end of procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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