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临床试验/NCT02234102
NCT02234102Unknown不适用

Eagle AF - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation

Prof. Dr. med. Bernd Lemke6 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2014年8月最近更新:
适应症

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

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

发起方
Prof. Dr. med. Bernd Lemke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dr. med. Bernd Lemke

Klinikdirektor der Klinik für Innere Medizin III

Märkische Kliniken GmbH

研究点 (6)

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