Totally Endoscopic Ablation of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs
研究概览
简要总结
Primary Objective To evaluate the efficiency of totally endoscopic ablation of AF compared to rate control management of AF.
Secondary Objectives
Does totally endoscopic ablation:
- reduce atrial fibrillation symptoms?
- increase working capacity and improve quality of life?
- improve atrial function?
- reduce the risk for stroke?
详细描述
This is a randomized open controlled single centre study that involves 60 patients (men and women) over the age of 50 years with longstanding persistent AF of more than one year duration and in the absence of other severe cardiopulmonary disease. One of the participating investigators informs the patient, both verbally and in writing, about the study and what participation in the study involves. The patient will be given time to ask questions and to consider study participation and can be enrolled in the study after signing and dating written Informed Consent. Study duration per patient is 12 months.
After inclusion, the patient will be divided into one of two groups, treatment group or control group, according to block wise randomization. The patient will be asked to complete two health related questionnaires SF 36 and SCL and a transthoracic echocardiography will be conducted together with an exercise test.
The patients will thereafter be assessed according to randomisation. Irrespective of group, the patients will be rescheduled for a visit within two months for totally endoscopic ablation and Reveal implantation or just Reveal implantation (control group). All patients will then be assessed during follow-ups after 1, 3, 6 and 12 months.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 50 years
- •Longstanding persistent AF of > 1 year duration
- •Severe symptoms related to AF
- •Have signed and dated Informed Consent.
- •Willing and able to comply with the protocol for the duration of the trial.
排除标准
- •Severe ischemic heart disease or heart valve disease
- •Thrombus formation in left atrial appendage
- •Intolerance to warfarin medication
- •Advanced pulmonary disease, FEV 1 < 1.5 litre
- •Left atrial diameter > 60 mm
- •Body Mass Index (BMI) > 35 kg/m2
- •Previous pulmonary or heart surgery
- •Participation in another clinical trial within the last 30 days prior to enrollment
研究组 & 干预措施
Endoscopic ablation of atrial fibrillation
干预措施: Endoscopic ablation of AF (Procedure)
Rate control
干预措施: Rate control (Drug)
结局指标
主要结局
Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs
时间窗: 3-12 months
次要结局
- Exercise capacity after 12 months(12 months)
- Freedom of symptomatic AF episodes 3 - 12 months(3-12 months)
- Quality-of-life assessment (SF-36 and SCL) 3, 6 and 12 months(12 months)
- Atrial function and dimensions after 6 and 12 months(12 months)
- Freedom of thromboembolic events during the study(12 months)
研究者
Anders Ahlsson
MD PHD
Region Örebro County