Comparative Assessment of Catheter and Thoracoscopic Approaches in Patients With Persistent and Long-standing Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Major adverse cardiac and cerebral events (MACCE)
研究概览
简要总结
Despite good progress in the management of patients with atrial fibrillation (AF), this arrhythmia remains one of the major causes of stroke, heart failure, sudden death, and cardiovascular morbidity in the world. Furthermore, the number of patients with AF is predicted to rise steply in the coming years.
Even if the amount of antiarrhythmic drugs (AAD) is constantly increasing, there is a group of patients who has AF, resistant to AAD therapy. In such cases they are being offered alternative minimally invasive procedures, such as catheter or thoracoscopic ablation. With the discovery that AF often is initiated and maintained by electrical instability inside and around the pulmonary veins (PV) catheter and thoracoscopic ablation are now widely accepted invasive strategies to cure AF.
Even though the results of both of the procedures are very promising in treating patients with paroxysmal AF, the decision making process, which approach should be used in patients with persistant or LSPAF, is still very controversial.
According to 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS, catheter or surgical ablation should be considered in patients with symptomatic persistent or long-standing persistent (LSP) AF refractory to AAD therapy to improve symptoms, considering patient choice, benefit and risk, supported by an AF Heart Team (IIaC).
Since, there is no actual evidence base, which approach is more effective and save in patients with persistant and LSP AF, the aim of the investigator's study is to evaluate the results of both of the approaches in such group of patients.
详细描述
The aim of this study is to compare 2 approaches for AF treatment, endocardial catheter isolation of the pulmonary veins (PV) versus minimally invasive thoracoscopic surgical epicardial ablation.
The patients in both groups will be comparable and have persistant or LSP AF only. Patients with previous catheter ablations or any interventions or open heart procedures in the anamnesis will be excluded. The catheter ablation will be Ablation Index-guided, which means that every ablation point will be taken according to ablation quality marker which corporates power, delivery time, contact force (CF), and catheter stability, called Ablation Index (AI). Both of the procedures will be performed by a single identical protocol including wide complete circumferential ablation around the right and left PVs, and additional lines between the lower and upper PVs. The thoracoscopic procedure will be supplemented with removal of left atrial appendage (LAA).
In cases of AF or other atrial tachycardia recurrence after both procedures, every patient will undergo the opposite procedure (for example, if patient after thoracoscopic ablation will be diagnosed an AF recurrence, he will undergo catheter ablation). That is why there will be the third group, the so-called Hybrid procedure group of patients.
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
- •Patient is older than 18 years old
- •Patient has nonparoxismal atrial fibrillation
- •Sympthomatic AF
- •Patient is refractory to at least one antiarrhythmic drug
- •Indications for catheter or thoracoscopic ablation
- •Absence of previous failed catheter or surgical AF ablations
- •Patients agreement
排除标准
- •Patient is younger than 18 years old
- •Contraindications for catheter or thoracoscopic ablation
- •Any previous heart surgeries (open/interventional)
- •Congenital heart diseases
- •Paroxismal AF
结局指标
主要结局
Major adverse cardiac and cerebral events (MACCE)
时间窗: 12 month
MACCE include death, stroke, transitory ischemic attack, hemopericarditis, implantation if pacemaker.
Freedom from AF and other atrial tachycardia
时间窗: 12 month
Freedom from AF and other atrial tachycardias, lasting more than 60 sec, determined by 24-hour Holter monitoring. Other atrial tachycardias include left atrial flutters, typical atrial flutters
次要结局
- Postoperative hospitalization duration(2 month)
- Freedom of AAD(12 month)
- Decrease in the frequency of AF episodes(12 month)
研究者
Revishvili Amiran Shotaevich
M.D., Ph.D., Academician of the Russian Academy of Science, Head of the A.V. Vishnevsky National Medical Research Center of Surgery
National Research Center of Surgery, Russia