Eagle AF - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- Documented recurrence of AF or any tachyarrhythmia lasting > 30 seconds
研究概览
简要总结
The study aims to compare the results of pulmonary vein isolation (PVI) with a single technology approach in patients suffering from paroxysmal atrial fibrillation (PAF) with patients who have persistent AF of less than 3 months. Many studies have shown that electrical reconnection of the pulmonary veins following the index procedure can occur in up to 40% of targeted veins leading to a recurrence of PAF. Endoscopically guided laser ablation utilising the HeartLight system (CardioFocus Inc., USA) has been shown to be safe and effective and has also shown promising rates of durable isolation compared to point by point radio frequency techniques. However, the impact of employing this technique for patients with persistent AF has not yet been reported. The study hypothesis is that there will be no statistically significant difference between the results of PVI in the two groups of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •failure of at least one specific class I or III antiarrhythmic drug (AAD)
- •left atrial size < 50 mm
- •left ventricular ejection fraction > 45%
- •specific for PAF: diagnosed with self-terminating episodes for no longer than 7 days
- •specific for persistent AF: diagnosed with episodes of > 7 days and < 90 days
排除标准
- •AF secondary to a reversible cause of non-cardiac origin
- •uncontrollable hypertension
- •left atrial thrombus
- •specific for PAF: more than 1 electrical cardioversion in the year prior to enrollment
- •specific for persistent AF more than 4 electrical cardioversions in the year prior to enrollment
结局指标
主要结局
Documented recurrence of AF or any tachyarrhythmia lasting > 30 seconds
时间窗: Between day 90 and 365 after index procedure
次要结局
- Number of electrical cardioversions needed(365 days after index procedure)
研究者
Prof. Dr. med. Bernd Lemke
Klinikdirektor der Klinik für Innere Medizin III
Märkische Kliniken GmbH
