Comparison of the Efficacy of Hybrid Ablative Therapy for Patients With Persistent Atrial Fibrillation Versus Conventional Catheter Ablation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 6
- 主要终点
- Atrial fibrillation (AF)/Atrial tachycardia (AT) recurrence
研究概览
简要总结
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence ranging from 5% over 60 years old to 17% after 85 years old. Besides hemodynamical compromises and occurrence of heart failure, stroke remains the most feared complication related to AF with a risk increased by 5-fold.
Catheter ablation with the aim of pulmonary veins isolation (PVI) has evolved as a standardized treatment option in paroxysmal AF (PAF), supported by the current guidelines. However, due to advanced electrical and structural remodeling, catheter ablation for persistent AF is rather disappointing with a limited success rate, at least after a single procedure. Due to these shortcomings, minimally invasive thoracoscopic surgical techniques have gained attention with good results in persistent AF patients. Comparison between thoracoscopic surgical ablation and catheter ablation have shown that surgical ablation was associated with higher success rates, less redo procedures but also with higher complication rates. The main issue with surgical ablation is the difficulty to check the ablation lines and pulmonary vein isolation, which are the cornerstones for achieving good long-term results.
Hybrid therapy, combining both epicardial surgical and endocardial catheter ablation is expected to be the most effective technique. It would avoid incomplete lesions or incomplete pulmonary vein isolation, and would provide complete lesion set. Hybrid therapy of AF has been compared with mini-invasive surgical ablation of AF, showing a significant higher rate of sinus rhythm achievement in the hybrid therapy group. However, no comparative clinical trials data are currently available in the setting of persistent AF comparing hybrid ablation and conventional catheter 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
- 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
- •To have a history of symptomatic persistent atrial fibrillation (AF) (continuous AF lasting 7 days or more) or long-standing persistent AF (continuous AF lasting for more than 12 months)
- •To be refractory to or intolerant to at least one class I (flecainide / propafenone) or III (sotalol / amiodarone) antiarrhythmic drug,
- •To be at least 18 years of age,
- •To agree to participate (signature of the informed consent)
排除标准
- •A previous AF ablation procedure,
- •A longstanding persistent AF > 3 years,
- •A paroxysmal AF
- •AF consecutive to electrolyte imbalance, thyroid disease, or other reversible non-cardiovascular cause,
- •Presence of left atrial appendage (LAA) thrombus,
- •Left atrial size ≥ 70ml/m² on transthoracic echocardiogram (TTE),
- •Left ventricular ejection fraction < 35%,
- •Cardiac surgery (other than AF treatment) planned within 12 months,
- •Contra-indication to heparin and/or oral anticoagulation
- •Contra-indication to transoesophageal echocardiogram (TEE)
- •Carotid stenosis > 80%,
- •Active infection or sepsis
- •Pleural adhesions,
- •Elevated hemi diaphragm
- •Proven and untreated sleep apnoea syndrome,
- •Occurrence of a cerebrovascular accident (CVA) or a transient ischemic attack (TIA) during the past 6 months,
- •History of blood clotting abnormalities
- •Indication for a permanent dual antiplatelet therapy
- •History of thoracic radiation,
- •History of myocarditis or pericarditisHistory of cardiac tamponade,
- •History of thoracotomy or cardiac surgery,
- •Body-mass-index > 40 kg/m2,
- •Significant lung dysfunction
- •Contra-indication to anesthesia
- •Patient with chronic obstructive pulmonary disease (COPD)
- •Pregnancy,
- •Life expectancy less than 12 months,
- •Adults protected by the law
研究组 & 干预措施
Hybrid ablation procedure
In the hybrid ablation procedure, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step procedure.
干预措施: Hybrid ablation (Procedure)
Percutaneous endocardial catheter ablation procedure
In the percutaneous catheter ablation arm, the procedure will be performed according to the current guidelines (pulmonary vein isolation, linear ablation and fragmented potentials ablation if needed, with the achievement of sinus rhythm during the procedure being the optimal endpoint).
干预措施: Percutaneous catheter ablation (Procedure)
结局指标
主要结局
Atrial fibrillation (AF)/Atrial tachycardia (AT) recurrence
时间窗: 12 months
occurrence of at least one episode of AF/AT \> 30 seconds in any ECG or Holter tracing (absence or presence)
次要结局
- Radiation exposure time(12 months)
- Antiarrhythmic drugs(12 months)
- AF/AT recurrence or major complication(12 months)
- Major complication related to the procedure(12 months)
- Major complication related to AF/AT(12 months)
- ICUR(12 months)
- Redo-procedure(12 months)
- Cardioversion(12 months)
- Number of hospitalizations(12 months)
- Radiation exposure dosage(12 months)
- Any complication (major or minor)(12 months)
- Duration of the hospitalization(1 month)
- Electrophysiological success(Day 0)
- Evolution of quality of life(Between baseline to 12 months)
- ICER(12 months)
- Production costs(during the surgical procedure)