Randomized Study Comparing Pulmonary Vein Isolation Alone vs. Pulmonary Vein Isolation Plus Electrogram-Guided Substrate Ablation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation
研究概览
简要总结
The purpose of this study is to compare two strategies of catheter-based treatment of paroxysmal atrial fibrillation: Pulmonary vein isolation either alone or combined with electrogram-guided substrate-ablation.
详细描述
Catheter ablation has evolved an accepted alternative in the curative treatment of atrial fibrillation (AF). However, discussion about the best ablation strategy is still ongoing.
In patients with paroxysmal AF, it has been reproducibly demonstrated that curing rates of approximately 65-70% can be achieved with the electric isolation of pulmonary veins (PV) eliminating the initiating triggers of AF episodes. Recently, a new catheter ablation approach targeting in both atria fractionated, complex electrograms during ongoing AF and modifying thus the substrate maintaining AF has been described. The first describer of this technique reports curing rates of 92%. We want to compare in a randomized prospective study the treatment by PV isolation alone with a combined approach of PV isolation together with ablation of fractionated complex electrograms in patients with paroxysmal AF. Study endpoint is the achievement of stable sinus rhythm as assessed by 7 days holter ECG in the absence of antiarrhythmic drug treatment.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and <80 years
- •Symptomatic paroxysmal atrial fibrillation
- •Drug-refractory
- •Anticoagulation
排除标准
- •Hyperthyreosis
- •Moderate-to-severe mitral valve valvulopathy
- •LV-ejection fraction <35%
- •Prior ablation, PCI or heart surgery <3 months
- •Left atrial thrombus
研究组 & 干预措施
1
trigger-guided ablation of paroxysmal atrial fibrillation
干预措施: trigger-guided catheter-ablation (Procedure)
2
trigger-+substrate guided ablation of paroxysmal atrial fibrillation
干预措施: trigger+substrate-guided catheter ablation (Procedure)
结局指标
主要结局
Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation
时间窗: Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation
次要结局
未报告次要终点
