跳至主要内容
临床试验/NCT02257112
NCT02257112已完成不适用

Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

Cardialen, Inc.1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2014年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
1
主要终点
Safety and Efficacy of Multistage low-energy pulses to organize, suppress, or terminate atrial fibrillation as determined by changes in atrial fibrillation cycle length, and atrial electrogram morphology.

研究概览

简要总结

Multistage low-energy pulses are being evaluated for their effect on atrial fibrillation during an acute testing procedure.

详细描述

This is a research feasibility study to evaluate various parameters of the multistage low-energy pulses and their effect on atrial fibrillation.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients indicated for an atrial fibrillation ablation procedure

排除标准

  • 未提供

研究组 & 干预措施

Multistage low-energy stimulation

Experimental

Multistage low-energy electrical pulses as described in Janardhan AH et al. JACC 2014 Jan7-14:63(1):40-8 will be delivered to a patient in atrial fibrillation. The responses to these stimuli will be recorded.

干预措施: Multistage low-energy stimulation (Device)

结局指标

主要结局

Safety and Efficacy of Multistage low-energy pulses to organize, suppress, or terminate atrial fibrillation as determined by changes in atrial fibrillation cycle length, and atrial electrogram morphology.

时间窗: Patients will be followed during the acute procedure which is expected to average 60 minutes

Multistage low-energy pulses are delivered to the atria of patients while in atrial fibrillation. The atrial electrograms will be recorded and used to evaluate if there was a change in the atrial fibrillation cycle length, increased organization of the arrhythmia using frequency analysis or if the pulses were able to terminate the atrial fibrillation.

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 (1)

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