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临床试验/NCT01169246
NCT01169246终止不适用

Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D Implanted Patients

MicroPort CRM1 个研究点 分布在 1 个国家目标入组 1,254 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1,254
试验地点
1
主要终点
Ventricular Tachyarrhythmia episode

研究概览

简要总结

Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.

详细描述

The efficacy rate of the ATP Auto-switch function, defined as the % of VT episodes successfully reduced, will be compared with 85%.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient has been implanted (primo implantation or replacement) with an ICD model PARADYM VR 8250, DR 8550, CRT 8750, CRT 8770 models or any similar or higher range device
  • ATP Auto-switch function is programmed ON

排除标准

  • Presence of a contra-indication to the ICD therapy
  • Life expectancy less than 12 months

结局指标

主要结局

Ventricular Tachyarrhythmia episode

时间窗: 2 years

% of VT episode successfully reduced by the ATP Auto-switch

次要结局

  • Arrhythmia incidence(2 years)

研究者

发起方
MicroPort CRM
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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