Pilot, Randomized,Single Blind Trial of Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- composite outcome measure of complications
研究概览
简要总结
This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation in patients with valvular heart disease and left atrium enlargement
详细描述
Preservation or appearance of AF(atrial fibrillation) after mitral valve surgery substantially reduce the number of excellent and good results of the operation in the long-term period, causing circulatory insufficiency, increased pulmonary hypertension, increasing the risk of thromboembolic events and stroke.
Significant predictors of AF after surgery are the initial size of the left atrium more than 6.0 cm, stenotic lesions and rheumatic genesis of mitral defect. 80% of patients in this group had AF during the first year after operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rheumatic mitral valve lesion
- •the absence a history of AF
- •sinus rhythm
- •left atrium size more than 6.0 cm
排除标准
- •refusal to participate in the study
- •aortic stenosis / regurgitation
- •coronary atherosclerosis
研究组 & 干预措施
without prevention
isolated mitral valve replacement or reconstruction, implantation of cardiac monitor
干预措施: cardiomonitor (Device)
group of prevention
mitral valve replacement or reconstruction with surgical prevention of AF (concomitant ablation of the left atrium) and implantation of cardiac monitor.
Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe.
干预措施: surgical prevention of atrial fibrillation (Procedure)
group of prevention
mitral valve replacement or reconstruction with surgical prevention of AF (concomitant ablation of the left atrium) and implantation of cardiac monitor.
Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe.
干预措施: cardiomonitor (Device)
结局指标
主要结局
composite outcome measure of complications
时间窗: up to 1 year
次要结局
- number of participants with freedom from AF according to the long-term ECG monitoring(1 year)
- transport function of the left atrium according to TTE (transthoracic echo)(1 year)