One Staged Hybrid Approach of Minimally Invasively Surgical/Catheter Ablation for Persistent Atrial Fibrillation: A Non-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Sinus rhythm maintenance rate
研究概览
简要总结
There are 10 million atrial fibrillation (AF) patients in China, and the patients are risk of stroke, heart failure and sudden death. Persistent AF is still a refractory disease, and single catheter ablation only has a success rate around 30-50%. Hybrid strategy consisting of thoracoscopic epicardial ablation and transvenous endocardial ablation seems to be an attractive procedure to improve the treatment of persistent AF. However, only a few centers reported their preliminary results, and the conclusions are controversial. The investigator previously reported a minimally invasive surgical ablation from left thoracoscope only and achieved good results. Recently, the investigator successfully explored a hybrid procedure combing this unique surgical technique and transvenous catheter ablation. Here, the investigator present a study to evaluate the efficacy and safety of this novel hybrid procedure. The hypothesis is that a hybrid approach is more efficient than surgical ablation alone in the treatment of persistent AF.
This study is a non-randomized controlled study within a single institution. Isolated persistent AF patients admitted to the cardiovascular surgery department of Shanghai Xinhua Hospital will be screened for enrollment of this study. The study will recruit 180 patients in total. Based on their own willingness, the patients will be divided into hybrid group and minimally invasive (MIS) group. The MIS group patients only have surgical ablation surgery from left thoracoscope as the investigator reported before, while the hybrid group patients will have additional transvenous catheter ablation after the surgical ablation is done during the same operation. The ratio of hybrid to MIS group is expected to be 1:1, so that each group contains 90 patients. The perioperative data is collected, and the patients will be followed for 6 months. The primary outcome is the rate of sinus rhythm at 6 months post operation. The secondary outcomes include off antiarrhythmic drug rate, perioperative complications, major cardiovascular events, stroke, left ventricular systolic function, medical expense, serum brain natriuretic peptide level and quality of life. The aim is to evaluate the efficacy and safety of this novel hybrid procedure, therefore to provide more evidence of the hybrid strategy in the treatment of persistent AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated atrial fibrillation, without structural heart disease.
- •Persistent atrial fibrillation (Af last time > 7 days, including persistent long standing atrial fibrillation)
- •Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication; symptomatic patients are those who have been aware of their AF at any time within the last 5 years before enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of these.
- •Patient admitted with intent to treat by either hybrid or surgical ablation
排除标准
- •Previous surgical ablation of atrial fibrillation
- •Concomitant other cardiac diseases which require surgery at the same procedure, such as heart valve disease, congenital heart disease, coronary disease, dilated cardiomyopathy etc.
- •With other forms of severe arrhythmia
- •Ejection fraction of left ventricle less than 30%
- •Anteroposterior diameter of left atrial over 60mm
- •Tumor, active infection, pregnancy.
- •Previous surgeries with left thoracotomy, or expected left pleural adhesion, such as history of tuberculosis infection, pleural effusion, pneumothorax etc.
- •Hyperthyroidism
- •Thrombosis within left atrial appendage
- •General conditions too weak to tolerate the surgeries
- •Patient's circumstance that precludes completion of follow-up and/or obtaining information from the 1-year follow-up
- •Other conditions not appropriate for this study based on the investigators' judgments
研究组 & 干预措施
Hybrid group
Minimally invasive surgical radiofrequency ablation of atrial fibrillation followed by catheterized radiofrequency ablation within the same procedure
干预措施: Radiofrequency ablation (Procedure)
MIS group
Minimally invasive surgical radiofrequency ablation of atrial fibrillation only
干预措施: Radiofrequency ablation (Procedure)
结局指标
主要结局
Sinus rhythm maintenance rate
时间窗: At 6 months after the surgery
Based on ECG results from 3 months and 6 months after the surgery. Any non-sinus rhythm lasting \>30 seconds captured on ECG at any time will be considered failure to maintain sinus rhythm
次要结局
- Serum brain natriuretic peptide level(6 months after the surgery)
- Off any antiarrhythmic drug rate(6 months after the surgery)
- Perioperative complications(Within 1 month after the surgery)
- Major cardiovascular events(Within 6 months after discharge)
- Left ventricular systolic function(At 6 months after the surgery)
- Stroke(Within 6 months after the surgery)
- Costs of treatment in Chinese Yuan(From surgery to 6 months after the surgery)
- Quality of life(6 months after the surgery)
研究者
Ju Mei
Professor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine