First Line Radiofrequency Ablation vs. Antiarrhythmic Drugs for Atrial Fibrillation Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- long-term success
研究概览
简要总结
The objective of this multicenter randomized study is to establish the effectiveness of treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with anti-arrhythmic drugs, by encircling the pulmonary veins with radiofrequency (RF) ablation, using the NaviStar® ThermoCool® catheter and the CARTO™ EP Navigation System. Effectiveness will be determined by comparing chronic success of ablation therapy versus anti-arrhythmic drug treatment, defined as patients with an absence of atrial tachycardias during 24 months of follow-up as determined by 7-days Holter and transtelephonic monitoring, and by 12-lead electrocardiogram (ECG) recordings.
详细描述
This study is a prospective, randomized, multicenter clinical study that will enroll in its first phase 40 patients. The study will be performed in 3 European hospitals. Patients will be randomized to either the RF ablation strategy or to the medication arm.
Hypothesis:
As first line therapy, catheter ablation improves the long-term success, health-economic outcomes and is equally safe compared to the best anti-arrhythmic medication treatment in a selected group of patients with paroxysmal atrial fibrillation.
Primary endpoint:
- long-term success, defined as patients free from any atrial fibrillation during 24 months after initial study treatment as determined by 7-days Holter and transtelephonic monitoring and by 12-lead ECG recordings.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained
- •Two or more documented symptomatic paroxysmal atrial fibrillation episodes during the last 6 months. Episodes should last longer than 30 seconds.
- •Patients should not be on anti-arrhythmic medication therapy (Class I, III or IV) for AF (other than for cardioversion) or are currently on antiarrhythmic drug (AAD) therapy for any other arrhythmia
排除标准
- •Patients who had a previous ablation for atrial fibrillation
- •Patients who had presence of severe valvular disease, myocardial infarction and/ or cardiomyopathy
- •Patients with a left atrial size more than 50 mm
- •Patients who had more than 2 cardioversions
- •Patients who have a history of AF for less than 3 months or more than one year
- •Patients with solely asymptomatic AF
- •Patients who have AF episodes triggered by another uniform arrhythmia
- •Patients who actively abuse alcohol or other drugs, which may be causative of AF
- •Patients with a tumor, or another abnormality which precludes catheter introduction
- •Patients with a revascularization or other cardiac surgery within 6 months before study treatment
- •Patients in whom appropriate vascular access is precluded
- •Patients with a contraindication to treatment with warfarin or other bleeding diathesis participants in another investigational clinical or device trial
- •Patients who are inaccessible for follow-up psychological problem that might limit compliance
- •Patients who cannot or will not fulfill the follow-up or protocol requirements
- •Pregnant women
- •Patients with severe chronic obstructive pulmonary disease
- •Patients with Wolff-Parkinson-White (WPW) syndrome
- •Patients with renal failure requiring dialysis
- •Patients with hepatic failure
结局指标
主要结局
long-term success
时间窗: 19 months
次要结局
- AF-burden(19 months)
- health-economic costs(24 months)
- serious adverse events(19 months)
- Quality of Life scores(19 months)