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临床试验/NCT03041519
NCT03041519Unknown不适用

Multi-center, Randomized, Controlled, Prospective Trial to Compare the Feasibility, Safety, and Efficacy of Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias.

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Procedural success rates

研究概览

简要总结

This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.

详细描述

Catheter ablation is a well-established treatment to treat patients with a wide range of heart rhythm disturbances. Fluoroscopy is a imaging modality routinely used for the ablation of arrhythmias.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs; three-dimensional mapping systems, including CARTO and Ensite NavX, have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Ensite NavX system can be used for zero-fluoroscopy approach for catheter ablation of arrhythmias. This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ventricular Tachycardia
  • Ventricular Premature Complexes

排除标准

  • Organic ventricular tachycardia or ventricular premature complexes
  • Drug-induced ventricular tachycardia or ventricular premature complexes

结局指标

主要结局

Procedural success rates

时间窗: 3 months

次要结局

  • Total procedure time(during procedure)
  • Complications(1 year)
  • Immediate success rate(10~30minutes)
  • Fluoroscopy time(during procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yan Wang

Professor

Tongji Hospital

研究点 (1)

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