跳至主要内容
临床试验/NCT02424110
NCT02424110Unknown不适用

Bipolar Radiofrequency Ablation Plus Endocardial Ablation Using Argon Beam Coagulator for Atrial Fibrillation Treatment in Patients With Rheumatic Heart Disease

Xinqiao Hospital of Chongqing1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
electrocardiogram:rates of cardioversion of atrial fibrillation

研究概览

简要总结

The objective of the study is to make up the technique blind spots of the bipolar radiofrequency ablation in the surgical treatment of atrial fibrillation with rheumatic heart disease by using argon beam coagulator. And to improve the rates of cardioversion of atrial fibrillation after surgery, to decrease the long-term recurrence rate of atrial fibrillation and to compare the early term and long term outcomes of bipolar radiofrequency ablation and bipolar radiofrequency plus argon beam coagulator ablation.

详细描述

Atrial fibrillation(AF) is the most common sustained arrhythmia. It can cause reduced heart function and increase the risk of thromboembolism. About 60% of patients with rheumatic heart disease have persistent AF.AF surgery is an effective intervention for patients with all types of AF undergoing concomitant cardiac surgery. AF surgery can reduce the risks of heart of stroke and heart failure and promote longer survival. Bipolar radiofrequency ablation is one of the most effective ways. But in the investigators' early study we find that there are technique blind spots in the left atrial ablation and right atrial ablation. In the bipolar left atrial linear ablation performed along the lower edge of interatrial groove incision up to the mitral annulus, there is a gap between the ends of the ablation line to the mitral annulus. And if the investigators use bipolar radiofrequency pliers it may injure the lcx left circumflex artery and left ventricular. In the bipolar right atrial radiofrequency ablation, the linear ablation performed along the lower edge of the coronary sinus ostium up to the inferoseptal commissure and the linear performed through the vertical incision on anterior wall of the right atrium up to the tricuspid annulus, there is also a gap between the end of the end of the ablation line and the tricuspid annulus. These gaps are one of factors of the recurrence of AF.

Argon beam coagulator is one of the most common hemostasis tools in heart surgery. It can also cause coagulation necrosis of the myocardium and do not do harm to the nearly myocardium the same as bipolar radiofrequency ablation. In the investigators' early study the investigators use the coagulation de plasma argon to burn the endocardium. And in the investigators' 6 mouth follow up, the rate of cardioversion is 90%. In this study the investigators plan to use argon beam coagulator to ablate these gaps.

The objective of the study is to make up the technique blind spots of the bipolar radiofrequency ablation in the surgical treatment of atrial fibrillation with rheumatic heart disease by using argon beam coagulator. And to improve the rates of cardioversion of atrial fibrillation after surgery, to decrease the long-term recurrence rate of atrial fibrillation and to compare the early term and long term outcomes of bipolar radiofrequency ablation and bipolar radiofrequency plusargon beam coagulator ablation.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients got atrial fibrillation with rheumatic heart disease need surgical radiofrequency ablation treatment

排除标准

  • left atrial diameter>65mm,
  • sick sinus syndrome,
  • atrioventricular block,
  • ventricular tachycardia,
  • reoperation patients,
  • implantation of permanent pacemaker,
  • NYHA(New York Heart Association) class IV,
  • Malignant tumor, or other serious diseases which life expectancy < 1 year,
  • Heating temperature above 38 degrees or active infection.

结局指标

主要结局

electrocardiogram:rates of cardioversion of atrial fibrillation

时间窗: 3 years after surgery

The investigators plan to check the electrocardiogram of all the 200 individuals involved in our study 3 years after surgery to ensure the rate of cardioversion of atrial fibrillation

次要结局

  • cardiopulmonary bypass time(during surgery)
  • hospital stays(4 weeks)
  • long-term recurrence rate of atrial fibrillation(3 years)
  • complication after surgery(3 years)
  • radiofrequency ablation time(during surgery)
  • surgery time(during surgery)

研究者

发起方
Xinqiao Hospital of Chongqing
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mingwen Li

Resident surgeon in the Department of Cardiovascular Surgery of Xinqiao Hospital

Xinqiao Hospital of Chongqing

研究点 (1)

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