跳至主要内容
临床试验/NCT00958165
NCT00958165已完成3 期

Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CFEAS- AC) for the Treatment of Symptomatic Atrial Fibrillation

CardioFocus3 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2009年8月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
CardioFocus
入组人数
81
试验地点
3
主要终点
Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.

研究概览

简要总结

The purpose of this study is to determine the safety and effectiveness of the endoscopic ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF) with pulmonary vein isolation (PVI).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Symptomatic, Paroxysmal atrial fibrillation (AF)
  • •18 to 70 years of age
  • •Failure of at least one AAD

排除标准

  • •Generally good overall health as determined by multiple criteria
  • •Willing to participate in a study

研究组 & 干预措施

EAS-AC

Experimental

PVI with EAS-AC

干预措施: CardioFocus EAS-AC (Device)

结局指标

主要结局

Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
CardioFocus
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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