Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion and Left Atrium Enlargement
Pilot, Randomized,Single Blind Trial of Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Novosibirsk、俄罗斯联邦、630055
- MeshalkinRI
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- rheumatic mitral valve lesion
- the absence a history of AF
- sinus rhythm
- left atrium size more than 6.0 cm
Exclusion Criteria:
- refusal to participate in the study
- aortic stenosis / regurgitation
- coronary atherosclerosis
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较:without prevention
isolated mitral valve replacement or reconstruction, implantation of cardiac monitor
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in both groups cardiac rhythm will be controlled by a cardiomonitor
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有源比较器: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. |
in both groups cardiac rhythm will be controlled by a cardiomonitor
Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery.
Ablation is performed by radiofrequency electrode or cryoprobe.
Pulmonary veins, posterior wall of the left atrium will be isolated by the scheme box-lesion with additional lines to the mitral valve and appendage of left atrium.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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composite outcome measure of complications
大体时间:up to 1 year
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up to 1 year
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次要结果测量
结果测量 |
大体时间 |
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number of participants with freedom from AF according to the long-term ECG monitoring
大体时间:1 year
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1 year
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transport function of the left atrium according to TTE (transthoracic echo)
大体时间:1 year
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1 year
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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