Verification of Half Normal Saline as a Superior Irrigant in the Catheter Radiofrequency Ablation of Typical Cavotricuspid Isthmus Dependent Atrial Flutter: A Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Time taken to produce bidirectional block
研究概览
简要总结
To assess the acute and long-term efficacy of half-normal saline compared to normal saline for irrigation of open-irrigated catheters during catheter ablation for the treatment of cavotricuspid isthmus dependent atrial flutter.
详细描述
It is unclear whether ionic strength affects energy delivery and ablation lesion size during radiofrequency ablation for atrial flutter. Given that saline contains ionic sodium and chloride in the solution, it has conductive properties that may disperse radiofrequency energy away from the tip-tissue interface, thereby reducing current density and lesion size compared to ablation with nonionic solutions. The efficacy of half-normal saline will be measured by the time taken to create bidirectional block across the cavotricuspid isthmus as well as the acute recurrence rate within 30 minutes of the initial occurrence of bidirectional block and the 1 year freedom from flutter recurrence.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years of age at the time of enrollment
- •Patients presenting for right sided typical atrial flutter ablation who have a clinical indication to undergo catheter ablation
- •Fully informed written informed consent by either the subject or subject's legal representative and ability for subject to comply with study responsibilities
排除标准
- •The presence of thrombus within the left atrial appendage
- •Prior catheter ablation of the cavotricuspid isthmus for right sided atrial flutter
- •The inability to provide consent or comply with study requirements
- •A predicted life expectancy of < 12 months
研究组 & 干预措施
Half-normal saline
Use of half-normal saline (0.45% NaCl) as an irrigant for open-irrigated ablation catheters
干预措施: Half Normal Saline 0.45% Infusion Solution Bag (Drug)
Normal saline
Use of normal saline (0.9% NaCl) as an irrigant for open-irrigated ablation catheters
干预措施: Normal Saline 0.9% Infusion Solution Bag (Drug)
结局指标
主要结局
Time taken to produce bidirectional block
时间窗: intraprocedural
Acute recurrence rate < 30 minutes of initial occurrence of bidirectional block
时间窗: intraprocedural
Freedom from atrial flutter recurrence
时间窗: 1 year
次要结局
- Time taken for termination of atrial flutter(intraprocedural)
- Total radiofrequency ablation time and procedural time(intraprocedural)
研究者
Dr. Benedict Glover
Staff electrophysiologist Schulich Heart Program, Associate Professor University of Toronto
Sunnybrook Health Sciences Centre