跳至主要内容
临床试验/NCT01520714
NCT01520714终止不适用

Effect of Posture on LV Transvenous Lead Capture Thresholds (EXPECT)

Baylor Research Institute1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2009年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
1
主要终点
Evidence of Change in Threshold of >1 Volt With Posture Changes

研究概览

简要总结

The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.

详细描述

Traditionally clinicians program the safety margins for the right atrial, right ventricular, and left ventricular leads two-times the capture thresholds. This safety margin is necessary for the right atrial and right ventricular outputs to prevent asystole during fluctuation of capture thresholds. This two-times safety margin may not be necessary for the left ventricular lead output and may be causing shorter device battery longevity. Newly implemented LV capture threshold management algorithms may help maintain a proper balance of safety margin and battery longevity. However, recent research conducted on automatic left ventricular capture measurement (LVCM) shows as much as 3.5 V daily variability in capture thresholds. In this same study, 18% of patients had >1.5 V LV threshold variability. A possible explanation for the variability of LV thresholds is lead stability. Small movements of the lead electrodes associated with movement of patient posture may account for daily fluctuation of capture thresholds. As heart failure patient care and therapies improve, CRT patients may survive longer than the projected longevities of their device. In order to minimize patient risks associated with device change-outs, care must be taken to maximize battery longevity while maintaining CRT pacing. Examining patient posture changes as a possible cause of threshold variability may guide clinicians to program more appropriate LV outputs with patient safety and device longevity in mind.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
否

入选标准

  • •Greater than 18 years of age and able to provide informed consent
  • •Planned placement of a Medtronic LV pacing lead and a Medtronic ICD generator with LVCM technology
  • •Geographically stable and able to follow-up for a period of at least six months post-procedure at The Heart Hospital Baylor Plano
  • •Willingness to comply with the requirements of the protocol

排除标准

  • •Life expectancy of less than six months
  • •Plans for or significant possibility of pregnancy during the required follow-up window
  • •Significant cardiovascular surgery planned within six months following ICD implant

研究组 & 干预措施

Medtronic passive fixation LV lead

Experimental

Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule

干预措施: Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead (Device)

Medtronic 4195 Active Fixation LV Lead

Experimental

Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule

干预措施: Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead (Device)

结局指标

主要结局

Evidence of Change in Threshold of >1 Volt With Posture Changes

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Effect of Posture on Left Ventricular (LV)... | 临床试验