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临床试验/NCT01088308
NCT01088308终止不适用

Hemodynamic Differentiation of Tachycardia Episodes Using Tissue Perfusion

Medtronic BRC2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2010年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
18
试验地点
2
主要终点
Change in hemodynamic state during all tachycardia

研究概览

简要总结

This research study is a prospective, single-center, feasibility study designed to assess the possibility to detect hemodynamic changes during tachycardia episodes using tissue perfusion.

详细描述

This study is being conducted to evaluate the feasibility to detect hemodynamic changes induced by supra-ventricular or ventricular tachycardia (SVT or VT) using tissue perfusion. Patients with a standard indication for either an electrophysiological study or an implantable cardioverter defibrillators(ICD) implant can be included into this study. Tissue perfusion and arterial blood pressure will be monitored and recorded throughout the electrophysiological procedure or ICD implant testing.

The study will be conducted in two consecutive phases. After completion of study phase I the study phase II will commence. Study phase I will be an acute non-invasive study in patients with an indication for an electrophysiological study, in whom tissue perfusion will be measured non-invasively with an epi-cutaneous tissue perfusion sensor. Phase II will be an acute invasive study in patients with an indication for the implantation of an ICD, in whom the tissue perfusion sensor will be placed in the surgically prepared device pocket on the muscular pectoralis or between the muscular pectoralis major and muscular pectoralis minor.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Indication for: an electrophysiological study with ventricular stimulation OR the implantation of an implantable cardioverter defibrillator (ICD)
  • Patient is at least 18 years old.
  • Patient is able and willing to give informed consent.

排除标准

  • 未提供

结局指标

主要结局

Change in hemodynamic state during all tachycardia

时间窗: <3 hours

The primary objective is to demonstrate for all tachycardia (supra-ventricular and ventricular tachycardia) a 90 % \[two sided confidence interval of 75-100 %\] agreement between the true hemodynamic state (stable or unstable) derived from arterial blood pressure measurement and the hemodynamic state determined by tissue perfusion

次要结局

  • Change in hemodynamic state during SVT(<3 hours)

研究者

发起方
Medtronic BRC
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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