Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters in Atrial Fibrillation Ablation
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Half-normal saline
干预措施: Half-normal saline (Drug)
Normal saline
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
Andrea Natale
Executive Medical Director
Texas Cardiac Arrhythmia Research Foundation
