Clinical Benefits of Additional Complex Fractionated Atrial Electrogram Targeted Catheter Ablation for Longstanding Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation
研究概览
简要总结
- Purpose of the study
- To compare clinical outcome, procedure time, complication rate of persistent atrial fibrillation patients between conventional additional linear ablation and additional complex fractionated atrial electrogram targeted catheter ablation.
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Scientific evidence of the study
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In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.
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drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.
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catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.
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However, there are no consensus for proper ablation strategy in longstanding persistent atrial fibrillation.
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additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial.
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Therefore, we will compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation.
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Methods
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Treatment of All patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation.
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there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study.
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study contents
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to evaluate superior ablation strategy in longstanding persistent atrial fibrillation
- compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation. both strategies are conventional ablation strategies being performed world-wide.
- compare complex fractionated atrial electrogram before and after linear 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
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation
排除标准
- •patients who do not agree with study inclusion
- •permanent AF refractory to electrical cardioversion
- •AF with valvular disease ≥ grade 2
- •Patients with left atrial diameter greater than 60mm
- •patients with age less than 19
研究组 & 干预措施
the operation to add in CFAE to conventional liner ablation
The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients
干预措施: atrial electrogram and liner ablation (Procedure)
only doing conventional liner ablation
The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation
干预措施: atrial electrogram and liner ablation (Procedure)
结局指标
主要结局
number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation
时间窗: 1 year
lifelong, checked per every outpatient clinic visit
次要结局
未报告次要终点