Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- At 3rd, 6th and 12th month's follow-up, to evaluate the rhythm status by ECG and 24-hour Holter and cardiac hemodynamic status by transthoracic echocardiography
研究概览
简要总结
The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control, improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure? 150 rheumatic valve patients with chronic atrial fibrillation (AF) having concomitant valve surgery were randomized to three groups: left atrial ablation group, bi-atrial ablation group, and Amiodarone group. All patients were scheduled followed up before discharge and at 3rd, 6th and 12th postoperative months. Standard 12-lead electrocardiography (ECG), 24-hour Holter and transthoracic echocardiography were used to determine the rhythm and cardiac hemodynamic status.
详细描述
The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control,improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure?
150 patients with chronic AF having concomitant cardiac surgery will be enrolled. Patients will underwent bi-atrial radiofrequency,left atrial radiofrequency or no radiofrequency procedure randomly. All the patients will receipt amiodarone 200 mg/day for 12 months postoperatively.
All patients were scheduled followed before discharge and at 3rd, 6th and 12th postoperative months.The following diagnostic procedures were performed
- Standard 12-lead electrocardiography
- Holter-ECG
- Transthoracic echocardiography
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with atrial fibrillation secondary to definite rheumatic valve disease
- •At least six months and no longer than 5 years of chronic atrial fibrillation
- •Age >=18 years and <=70 Patients who can give informed consent themselves in writing
- •No contraindication for amiodarone
- •Negative pregnancy test (in women with childbearing potential)
排除标准
- •Any one of the following exclusion criteria is sufficient to disqualify a patient from the study
- •Left atrial diameter(LAD)>=70mm
- •Left ventricular eject fraction(LVEF)<=30%
- •Atrial thrombus
- •Contraindication for anticoagulation therapy
- •Less than 6 months since last episode of cerebral infarction
- •Emergency operation
- •Patients with a malignant tumor
- •Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
- •Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
结局指标
主要结局
At 3rd, 6th and 12th month's follow-up, to evaluate the rhythm status by ECG and 24-hour Holter and cardiac hemodynamic status by transthoracic echocardiography
时间窗: 1 year
次要结局
未报告次要终点