Evaluation of Proper Radiofrequency Catheter Ablation Strategy for the Patients Who Were Changed to Paroxysmal Atrial Fibrillation From Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 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 patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation between ablation with conventional pulmonary vein isolation and ablation with conventional pulmonary vein isolation with conventional linear 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 patients who were changed to paroxysmal atrial fibrillation from 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 pulmonary vein isolation with additional conventional linear 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
- to evaluate superior ablation strategy in patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
- compare conventional pulmonary vein isolation with additional liner ablation, both strategies are conventional ablation strategies being performed world-wide.
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
linear ablation
The group of positive control is the operation to add in conventional liner ablation to conventional pulmonary vein isolation with in patients based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
干预措施: linear ablation (Procedure)
pulmonary vein isolation
The group of negative is the operation to patients with only pulmonary vein isolation based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
干预措施: pulmonary vein isolation (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