跳至主要内容
临床试验/NCT00959205
NCT00959205Unknown4 期

Phase Ⅳ Study of CARTO 3D Mapping System vs Conventional Method in AF & VT

Korea University6 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
4 期
入组人数
160
试验地点
6
主要终点
Procedural duration

研究概览

简要总结

The purpose of this study is to evaluate the efficacy and safety of electroanatomic imaging compared to conventional method in patients with VT.

详细描述

To evaluate the efficacy and safety of electroanatomic imaging (CARTO) compared to conventional fluoroscopically guided activation mapping (Conventional) method in patients with Atrial Fibrillation and Substrate-dependent Ventricular Tachycardia To evaluate cost-effectiveness of CARTO 3D image system compared to conventional method in the same study subjects

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with AF or substrate-dependent VT

排除标准

  • administering with anticoagulants

结局指标

主要结局

Procedural duration

时间窗: 24weeks

Time from after puncture to catheter remover

Fluoroscopic time

时间窗: 24weeks

Total duration of procedure using fluoroscopy on , in minute

次要结局

  • Cost Effectiveness(24weeks)
  • Procedural Success(24weeks)
  • Morphology of ablation(24weeks)
  • Ablation time(24weeks)
  • Complications(24weeks)
  • Clinical Success(24weeks)
  • Radiation dose(24weeks)
  • Survival Rate(24weeks)

研究者

申办方类型
Other

研究点 (6)

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