NCT02630914已完成不适用
Medical and Surgical Hybrid Treatment of Atrial Fibrillation: Epicardial and Endocardial Combined Approach.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of participants with complete procedure or not
研究概览
简要总结
The objective of the study is to investigate the feasibility of a hybrid procedure removal of the atrial fibrillation.
This is a single procedure for both surgical epicardial by minimally invasive route (Thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal intracavitary route at the same time.
This faster procedure combined with complete lesions have a higher success rate and less frequent re-hospitalizations of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •patients with complex AF defined by the following criteria :
- •AF> 1 week or long term persistent> 1 year
- •AND Symptomatic
- •AND after failure of treatment of anti-arrhythmic or against-indication for anti-arrhythmic
排除标准
- •The exclusion criteria are relevant contraindications thoracoscopy or the non-complex nature of the AF:
- •Paroxysmal AF or AF cardioverted anti-arrhythmic test (unless against indicated)
- •Recent AF for which a simple gesture is intracavitary considered sufficient
- •Permanent AF
- •Asymptomatic AF
- •Very old AF (> 5 years) or atrial major ectasia (> 60 mm)
- •Need another surgery (valve bypass coronary)
- •Previous history of sternotomy or thoracotomy
- •High-risk surgical or anesthetic Patient
- •Sleep Apnea
- •Ejection fraction <35%
- •Thoracic trauma history
- •Veins Pulmonary stenosis> 50%
- •Hyperthyroidism
- •Thrombus in LAA
结局指标
主要结局
Number of participants with complete procedure or not
时间窗: 3 hours
At the end of the intervention, the doctor evaluates whether the procedure was complete with electric exclusion of the posterior wall of the left atrium and the 4 pulmonary veins.
次要结局
- Hospitalization for heart failure(12 months)
- Stroke Rate(12 months)
- Evaluation of Quality of life (EQ-5D according to the survey-3L)(12 months)
- Number of atrial fibrillation episode(12 months)
- The cost-effectiveness ration(12 months)
研究者
研究点 (2)
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