NCT02825498Unknown不适用
Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter
Victoria Cardiac Arrhythmia Trials1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年5月18日最近更新:
适应症
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
- Efficacy of RFA
研究概览
简要总结
Radiofrequency ablation (RFA) is a standard treatment option for cavotricuspid isthmus (CTI) dependent atrial flutter. We plan to perform a randomized prospective trial comparing the efficacy of contact force (CF) guided CTI ablation against catheter ablation with the operator blinded to contact force parameters.
详细描述
Subjects will be followed for one year post procedure in order to check for atrial flutter recurrences. This will involve an in-person visit at 3 months post procedure, and records checks at 12 months post procedure.
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
- 是
入选标准
- •Adult patients (over the age of 18) with 12 lead ECG documented paroxysmal or persistent CTI dependent atrial flutter planned to undergo CTI ablation.
- •Able and willing to give informed consent.
排除标准
- •Previous CTI ablation
- •Previous non-CTI dependent atrial flutter (ie.patients with previous history of pulmonary vein isolation or left atrial ablation, congenital heart disease, surgical ablation)
结局指标
主要结局
Efficacy of RFA
时间窗: Determined during RFA procedure
Total RFA time required to achieve bidirectional block
次要结局
- Recurrence of atrial flutter(Assessed at 12 weeks and 12 months post CTI RFA procedure)
- Average total CF achieved(Determined during RFA procedure)
- Average axial CF achieved(Determined during RFA procedure)
- Average FTI achieved(Determined during RFA procedure)
- Average lateral CF achieved(Determined during RFA procedure)
- Average lesion size index (LSI) achieved(Determined during RFA procedure)
- Procedural complication rate(Determined during RFA procedure and at 12 weeks post RFA procedure)
- Average total CF of segment of acute and delayed reconnection(Determined during index and repeat RFA procedure)
- Average lateral CF of segment of acute and delayed reconnection(Determined during index and repeat RFA procedure)
- Average axial CF of segment of acute and delayed reconnection(Determined during index and repeat RFA procedure)
- Average FTI of segment of acute and delayed reconnection(Determined during index and repeat RFA procedure)
- Procedural efficacy of RFA(Determined during RFA procedure)
- Average lesion size index (LSI) of segment of acute and delayed reconnection(Determined during index and repeat RFA procedure)
研究者
研究点 (1)
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