跳至主要内容
临床试验/NCT03498586
NCT03498586已完成不适用

Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters in Atrial Fibrillation Ablation

Texas Cardiac Arrhythmia Research Foundation2 个研究点 分布在 2 个国家目标入组 99 人开始时间: 2018年5月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
99
试验地点
2
主要终点
acute pulmonary veins, and left atrial appendage (if applicable) reconnection

研究概览

简要总结

The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during atrial fibrillation ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Half-normal saline

Experimental

干预措施: Half-normal saline (Drug)

Normal saline

Active Comparator

干预措施: Normal saline (Drug)

结局指标

主要结局

acute pulmonary veins, and left atrial appendage (if applicable) reconnection

时间窗: intraprocedural

total radiofrequency ablation time, and total procedure time

时间窗: intraprocedural

freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs

时间窗: 1 year

次要结局

  • freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs(1 year)
  • long-term pulmonary veins, left atrial appendage (if applicable), and coronary sinus (if applicable) reconnection(in case of a repeat procedure performed during the study follow-up (an average of 1 year))

研究者

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

Andrea Natale

Executive Medical Director

Texas Cardiac Arrhythmia Research Foundation

研究点 (2)

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