Evaluation of the Safety and Efficacy of Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation Using Point-by-Point Bipolar Pulsed Field Ablation Combined With Thermal Ablation of the Superior Paraseptal Parasympathetic Ganglion Region
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Recurrence of atrial fibrillation
研究概览
简要总结
Pulsed-field ablation (PFA) is a novel, non-thermal method for the treatment of atrial fibrillation (AF). It uses short, high-voltage electrical pulses to selectively ablate cardiomyocytes. PFA has demonstrated a high safety profile with reduced complication rates compared to thermal ablation.
Thermal ablation of parasympathetic ganglia during conventional pulmonary vein isolation (PVI) may improve long-term procedural outcomes by reducing AF recurrence. However, due to its non-thermal nature, PFA may not significantly affect cardiac autonomic innervation, which could be clinically relevant in vagally mediated AF or tachycardia-bradycardia syndrome.
This randomized study compares two strategies: (1) PFA-only PVI, and (2) PFA combined with selective thermal ablation (radiofrequency energy) of the superior paraseptal parasympathetic ganglion. The primary objective is to evaluate whether adjunctive thermal ablation improves clinical outcomes and reduces intraprocedural bradyarrhythmic events.
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
- Single (Participant)
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
- •Age ≥18 years
- •Documented paroxysmal atrial fibrillation (AF) lasting ≥30 seconds on ECG or Holter monitoring
- •Willingness and ability to provide written informed consent
- •Life expectancy >1 year
排除标准
- •Persistent AF lasting >7 days or long-standing AF >1 year
- •Secondary AF due to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-cardiac causes
- •Left atrial anteroposterior diameter ≥45 mm on transthoracic echocardiography
- •Clinically significant coexisting arrhythmias other than AF
- •Significant valvular heart disease or valve prosthesis
- •Chronic heart failure NYHA class III/IV
- •Previous AF or atrial flutter ablation
- •Prior closure of atrial septal defect or left atrial appendage
- •Atrial myxoma
- •Implanted pacemaker or defibrillator
- •History of pericarditis
- •Congenital heart disease
- •Coagulopathy or bleeding disorders
- •Contraindications to oral anticoagulation
- •Contraindications to CT or MRI
- •Pregnancy or breastfeeding
- •Body Mass Index >30
- •History of organ transplantation
- •Severe pulmonary disease
- •Estimated Glomerular Filtration Rate <30 mL/min/1.73 m²
- •Active malignancy
- •Significant infection
- •Life expectancy <1 year
- •Psychiatric disorders preventing study participation
- •Refusal or inability to provide informed consent
结局指标
主要结局
Recurrence of atrial fibrillation
时间窗: 12 months post-procedure
Any symptomatic or asymptomatic episode of atrial fibrillation lasting \>30 seconds, confirmed by ECG or Holter monitoring.
次要结局
- Intraprocedural bradyarrhythmic episodes(During ablation procedure)
- Requirement for intraprocedural cardioversion(During ablation procedure)
研究者
Łukasz Zarębski
MD
St. Joseph's Centre, Poland