A Randomised Comparison of Left and Right Sided Approaches to Ablation of the Atrioventricular Junction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparison of total ablation time required to induce complete atrioventricular node block
研究概览
简要总结
This study will compare right sided atrioventricular node ablation to left sided atrioventricular node ablation
详细描述
Right-sided atrioventricular node ablation has been the initial conventional approach however up to 18.5% of patients require switching to a left sided approach or have a challenging procedure. Previous studies have found that left sided ablation is more efficacious than right-sided ablation requiring less than 5 applications of radiofrequency energy to induce atrioventricular block.
This study will compare right sided atrioventricular node ablation to left sided atrioventricular node ablation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age greater than or equal to 18 years
- •Referred for atrioventricular node ablation for any such indication
排除标准
- •Stroke or transient ischaemic attack (TIA) within 6 months
- •Myocardial infarction within 6 months
- •Medical conditions limiting expected survival to <1 year
- •Moderate to severe aortic stenosis
- •History of aortic or mitral valve replacement
- •Pregnancy or breast feeding women
研究组 & 干预措施
Right sided atrioventricular node ablation
Right sided atrioventricular node ablation
干预措施: atrioventricular node ablation (Procedure)
Left sided atrioventricular node ablation
Left sided atrioventricular node ablation
干预措施: atrioventricular node ablation (Procedure)
结局指标
主要结局
Comparison of total ablation time required to induce complete atrioventricular node block
时间窗: intraoperative
Time in seconds
次要结局
- Comparison of rate of the escape rhythm after ablation in beats/min(intraoperative)
- Comparison of number of patients requiring crossover to each side(intraoperative)
- Comparison of adverse events / complications between each group(intraoperative)
- Comparison of patient comfort of procedure(intraoperative)
- Comparison of number of RF applications required to induce complete atrioventricular node block(intraoperative)
- Comparison of total procedure time between the two groups(intraoperative)
- Comparison of radiation exposure between the two groups(intraoperative)
研究者
Rick Veasey
Principal Investigator
East Sussex Hospitals NHS Trust