A Prospective,Single Center, Randomized Controlled Trial of Quantitative Ablation of Pulmonary Vein Vestibule in Patients With Paroxysmal Atrial Fibrillation..
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Success rate of the pulmonary vein single-circle isolation.
研究概览
简要总结
The purpose of this trial is to explore the optimal AI value for isolating the pulmonary veins and achieving left ventricular apex and mitral isthmus block. Patients with atrial fibrillation who are scheduled to undergo catheter ablation will be randomized to different groups, then every group receive circumferential pulmonary vein isolation with different AI values. The relevant indicators such as the proportion of pulmonary vein single-circle isolation, operation time, the incidence of complications, and the proportion of recurrence of atrial fibrillation and other atrial arrhythmias after 1 year were collected.
详细描述
This is a prospective, single-center, randomized controlled trial. In this part,a total of 90 patients with paroxysmal atrial fibrillation who are scheduled for catheter ablation were randomly divided into 3 groups, 30 patients in each group. For the first group, the AI target value for the front wall and the top wall is 550, and the rear wall and the lower wall are 400. For the second group, the AI target values for the front wall and the top wall are 500, the rear wall and the lower wall are 350. For the third group, the AI target values for the front wall and top wall are 450, the rear wall and the lower wall are 300. The pressure value at each point is 5-15 g, and the distance between adjacent ablation points is less than 5 mm. The relevant indicators such as single-circle isolation rate of the pulmonary vein, operation time, the left atrial operation time, and the supplemental ablation site are recoded. The incidence of intraoperative and postoperative complications such as stroke, pericardial tamponade and steam pop during ablation are observed. Dynamic electrocardiography is performed during the follow-up period to evaluate the proportion of sinus rhythm within 1 year.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients enrolled in the study were randomly assigned to different surgical groups using random envelopes. All study personnel were blind to treatment allocation and had no way of influencing whether a participant would receive high or low AI ablation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant female subjects, 18≤age≤
- •Receiving or able to tolerate anticoagulant therapy.
- •Diagnosis of atrial fibrillation using an electrocardiogram or a dynamic electrocardiogram
- •The longest duration of atrial fibrillation episode is less than 7 days
- •Patient is compliant and willing to complete clinical follow-up.
排除标准
- •Patients who have previously undergone catheter ablation of atrial fibrillation;
- •Left ventricular ejection fraction <35%;
- •Pregnancy, planned pregnancy or lactating women;
- •Left atrial appendage thrombosis was detected by transesophageal ultrasound or intracardiac ultrasound;
- •Abnormal blood system or liver and kidney function;
- •Combined with severe organic heart disease (including congenital heart disease, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, and patients with myocardial infarction or coronary artery bypass grafting);
- •Patients who are considered unsuitable for inclusion by the investigator.
结局指标
主要结局
Success rate of the pulmonary vein single-circle isolation.
时间窗: Immediately after ablation
Success rate of the pulmonary vein single-circle isolation.
次要结局
- Left atrial operation time.(Immediately after ablation)
- Number of steam pop during ablation.(Immediately after ablation)
- the proportion of sinus rhythm within 1 year(1 year)
- Recurrence rate of atrial fibrillation(1 year)
- The location and number of supplemental ablation.(Immediately after ablation)
- Intraoperative and postoperative pericardial tamponade rates.(From the start of procedure to 7 days after ablation)
- Total procedure time.(Immediately after ablation)
- Intraoperative and postoperative stroke rates.(From the start of procedure to 7 days after ablation)
研究者
Yuehui Yin
Director of the Department
The Second Affiliated Hospital of Chongqing Medical University