跳至主要内容
临床试验/NCT01765075
NCT01765075已完成不适用

Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment

Boston Scientific Corporation2 个研究点 分布在 2 个国家目标入组 25 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Record 20 sets of electrophysiological data with a multi-electrode mapping catheter.

研究概览

简要总结

The purpose of the study is to gather electrophysiological data using a multi-electrode mapping catheter during a clinically indicated cardiac ablation procedure for the treatment of persistent atrial fibrillation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law
  • Scheduled for a clinically indicated cardiac ablation for the treatment of persistent atrial fibrillation
  • Able to meet study requirements for follow-up visit

排除标准

  • Permanent leads or presence of prosthetic or severely stenotic tricuspid or mitral valves
  • Active systemic infection or sepsis
  • Echocardiographically confirmed presence of thrombus
  • Atrial thrombus, myxoma, inter-atrial baffle patch or occluder device for those subjects in whom a transseptal approach is required
  • Subjects who cannot be anticoagulated or infused with heparinized saline
  • Heparin induced thrombocytopenia
  • Hemodynamic instability or shock
  • Atrial anatomy contradictory to catheter labeling or size indices
  • EF < 35%
  • Subjects with an active heart failure decompensation

结局指标

主要结局

Record 20 sets of electrophysiological data with a multi-electrode mapping catheter.

时间窗: Acute - time of procedure

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验