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临床试验/NCT02307188
NCT02307188已完成不适用

Atrial Signal Analysis Using a Multipolar Catheter in Patients Undergoing Atrial Fibrillation and Flutter Ablations

Angelo Biviano1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5
试验地点
1
主要终点
Atrial Fibrillation Dominant Frequency

研究概览

简要总结

This clinical investigation utilizes the Constellation Full Contact Mapping catheter in the left and right atria to explore atrial signal characteristics that can guide atrial fibrillation and atrial flutter ablation procedures more effectively.

详细描述

Atrial fibrillation (AF) and atrial flutter (AFL) are the most common cardiac arrhythmias in adults, and account for a substantial portion of patient morbidity and healthcare expenditures. Great effort has been put forth to discover effective treatments for AF/FL. Promising results of catheter ablation suggest that AF/FL may be eliminated in a majority of patients. For example, data from numerous laboratories shows that up to 85 percent of patients with the paroxysmal form of AF may be free of recurrences and off anti-arrhythmic drugs at one year follow-up.

研究设计

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

入排标准

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

入选标准

  • Patients referred to the PI (Dr. Biviano) or co-investigators in the Program of Cardiac Electrophysiology at Columbia University Medical Center who are scheduled to undergo ablation will be approached for recruitment:
  • Older than 45 years of age
  • History of AF and/or AFL and are candidates for catheter ablation.

排除标准

  • Patients not fitting the above clinical criteria or unwilling to comply with the instructions of the monitor are excluded, as well as patients with the following:
  • Permanent leads or prosthetic or stenotic valves present
  • Active systemic infection
  • Echocardiographically-confirmed visual presence of thrombus
  • For whom the inability of obtaining vascular access exists
  • Heparin-induced thrombocytopenia
  • Hemodynamic instability or shock

结局指标

主要结局

Atrial Fibrillation Dominant Frequency

时间窗: 1 year

Electrogram signal analysis will be performed to assess the dominant frequency of the atrial fibrillation electrograms collected by this catheter. These values will be correlated to patient outcomes.

次要结局

未报告次要终点

研究者

发起方
Angelo Biviano
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Angelo Biviano

Associate Professor of Medicine

Columbia University

研究点 (1)

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