Randomised Trial Comparing Conventional Versus Contact Force and Electrical Coupling Index in Atrial Flutter Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Time to achieve bi-directional block
研究概览
简要总结
Catheter ablation is now routinely used in the management of heart rhythm disorders. One of the problems with the approach is that it has not been possible to determine whether the ablation catheter is in direct contact with the heart tissue or not. This is important because too much contact has safety implications and too little means that the therapy will be ineffective. Recently two different technologies have been developed to determine contact. Currently it is not know if one is superior to the other, and the objective of this trial is to determine whether there is a difference when treating a rhythm called atrial flutter.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Documented paroxysmal or persistent atrial flutter
排除标准
- •Inability or unwillingness to receive oral anticoagulation
- •Previous ablation procedure for AFL
- •Unwillingness or inability to complete the required follow up arrangements
- •Concomitant atrial fibrillation
研究组 & 干预措施
ECI unblinded
干预措施: Ablation Catheter (Device)
ECI blinded
干预措施: Ablation Catheter (Device)
Contact force unblinded
干预措施: Ablation Catheter (Device)
Contact force blinded
干预措施: Ablation Catheter (Device)
结局指标
主要结局
Time to achieve bi-directional block
时间窗: up to 60 Seconds
Time to achieve bi-directional block (secs) . This is defined as the time from the first lesion to the time that consistent (\< one minute) bidirectional block is achieved. Total RF energy required for the whole procedure (sec), and total energy required for ablation (power x ablation time in secs).
次要结局
未报告次要终点