A Randomized Study That Will Show the Effects of Catheter Ablation Compared to the Effects of Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Presence of sinus rhythm
研究概览
简要总结
Patents with atrial fibrillation can be treated with the purpose of curing the arrhythmia.This may be achieved by catheter ablation and Maze surgery where the latter includes open heart surgery.
By catheter ablation the arrhythmia can be cured in about 70 % of patients who have episodes of atrial fibrillation. In patients with permanent atrial fibrillation the results are not as good.
We will compare a conventional ablation approach where lesions are created on the inside of the heart with a thoracoscopic approach where the lesions are created from the outside of the heart.
详细描述
Patients with permanent atrial fibrillation will be considered for randomisation Patients will be randomised to either conventional endocardial catheter ablation or epicardial thoracoscopic ablation.
Objectives of study:
Primary endpoint:presence of sinus rhythm after 6 months Secondary endpoints: complications, cost-effectiveness, structural changes (evaluated by echocardiography), p-BNP and inflammatory markers, atrial fibrillation burden evaluated by Holter monitoring
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Permanent atrial fibrillation documented on at least 2 ecg´s with more than 1 month between ecg´s. The diagnosis is verified on Holter.
- •All patients have symptoms or do not tolerate rate control treatment.
排除标准
- •Psychiatric disease or suspicion of incapability to give informed concent
- •Females with birth giving potential
- •Previous heart surgery
- •Previous ablation for atrial fibrillation
- •Life expectance less than 1 year
- •Congenital heart disease
- •Expected need for heart surgery
- •Heart failure (NYHA class IV)
- •Inability to be treated with anticoagulation
- •In case of previous deep venous thromboembolism og stroke the investigators will individually consider if the patient is suitable for inclusion.
结局指标
主要结局
Presence of sinus rhythm
时间窗: after 6 months from treatment
次要结局
- Quality of life(at 3 months from treatment)
- complications(during 12 months from treatment)
- cost-effectiveness(during 12 months from treatment)
- structural changes (evaluated by echocardiography)(during 12 months from treatment)
- p-BNP(during 12 months from treatment)
- inflammatory markers(during 12 months from treatment)
- atrial fibrillation burden evaluated by Holter monitoring(at 6 months from treatment)
- exercise performance(at 3 months from treatment)