Comparison of Pulmonary Vein Isolation Alone Versus Pulmonary Vein Isolation With Posterior Wall Isolation for Pulse-Field Ablation in Persistent Atrial Fibrillation: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 482
- 试验地点
- 2
- 主要终点
- Recurrence of atrial tachyarrhythmia
研究概览
简要总结
To date, no optimal treatment has been established to improve outcomes in patients with persistent atrial fibrillation. The safety and efficacy of pulsed-field ablation (PFA) have been demonstrated in several studies, and its clinical application is expanding.
- In patients with persistent atrial fibrillation, can the addition of posterior wall isolation (PWI) following pulmonary vein isolation (PVI) using PFA reduce recurrence?
Participants will:
- Undergo either PVI alone or PVI with additional left atrial posterior wall isolation (PWI)
- Visit the clinic to assess for recurrence of atrial tachyarrhythmias
详细描述
Atrial fibrillation is a major cardiovascular disease, and catheter ablation has become an established rhythm-control strategy that provides superior outcomes compared with pharmacological therapy in patients with drug-refractory atrial fibrillation. Although the efficacy of pulmonary vein isolation (PVI) is well established in patients with paroxysmal atrial fibrillation, the effectiveness of additional ablation strategies beyond PVI remains uncertain in patients with persistent atrial fibrillation.
Several studies have suggested that left atrial posterior wall isolation (PWI) may help reduce recurrence; however, conventional thermal ablation techniques have been limited by technical challenges in achieving durable lesion formation. Pulsed field ablation (PFA) is a nonthermal ablation technology that creates selective myocardial lesions, enabling rapid and consistent lesion formation while minimizing injury to surrounding tissues.
This study aims to prospectively and randomly compare PVI alone using PFA with PVI followed by additional PWI in patients with persistent atrial fibrillation. By evaluating recurrence rates, procedure time, complications, atrial fibrillation burden, and patient satisfaction, this study seeks to identify the optimal ablation strategy for patients with persistent atrial fibrillation.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 20 to 80 years who are candidates for catheter ablation for persistent atrial fibrillation
- •Patients eligible for catheter ablation according to existing clinical guidelines
- •Those without clinically significant structural heart disease (e.g., severe mitral regurgitation)
- •Those without contraindications to anticoagulation therapy
排除标准
- •Atrial fibrillation associated with severe congenital heart disease or structural heart disease
- •Patients with contraindications to general anesthesia or sedation for the procedure
- •History of prior cardiac surgery (e.g., Maze procedure, coronary artery bypass grafting)
- •History of atrial fibrillation catheter ablation within the past 12 months
- •Patients with severe left ventricular dysfunction (left ventricular ejection fraction <30%)
- •Patients with active internal bleeding
- •Patients with contraindications to anticoagulation therapy and antiarrhythmic drugs
- •Valvular atrial fibrillation (e.g., mitral stenosis > grade 2, mechanical valve, prior mitral valve repair)
- •Patients with severe comorbid conditions
- •Patients with an expected survival of less than one year
- •Patients with drug or alcohol addiction
- •Pregnant or breastfeeding women
- •Any other conditions deemed by the investigator to make the patient unsuitable for study participation
研究组 & 干预措施
Additional Left Atrial Posterior Wall Ablation Group
Pulmonary vein isolation (PVI) is performed as the primary procedure. After PVI, direct current (DC) cardioversion is performed to restore normal sinus rhythm. If the patient converts to sinus rhythm, they are randomly assigned to either the PVI-only group or the additional left atrial posterior wall ablation group. Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization. Patients assigned to this group after successful conversion to normal sinus rhythm by electrical cardioversion following PVI will undergo additional left atrial posterior wall isolation using pulsed field ablation. Before completion of the procedure, electrical isolation of both the pulmonary veins and the left atrial posterior wall will be confirmed. Thereafter, anticoagulation therapy and rhythm follow-up will be performed according to the study protocol.
干预措施: Pulmonary Vein Isolation (Procedure)
Additional Left Atrial Posterior Wall Ablation Group
Pulmonary vein isolation (PVI) is performed as the primary procedure. After PVI, direct current (DC) cardioversion is performed to restore normal sinus rhythm. If the patient converts to sinus rhythm, they are randomly assigned to either the PVI-only group or the additional left atrial posterior wall ablation group. Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization. Patients assigned to this group after successful conversion to normal sinus rhythm by electrical cardioversion following PVI will undergo additional left atrial posterior wall isolation using pulsed field ablation. Before completion of the procedure, electrical isolation of both the pulmonary veins and the left atrial posterior wall will be confirmed. Thereafter, anticoagulation therapy and rhythm follow-up will be performed according to the study protocol.
干预措施: Additional Left Atrial Posterior Wall Ablation (Procedure)
Pulmonary Vein Isolation (PVI) only Group
Pulmonary vein isolation (PVI) is performed as the primary procedure. After PVI, direct current (DC) cardioversion is performed to restore normal sinus rhythm. If the patient converts to sinus rhythm, they are randomly assigned to either the PVI-only group or the additional left atrial posterior wall ablation group. Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization. Patients assigned to this group after successful conversion to normal sinus rhythm by electrical cardioversion following PVI will undergo no additional left atrial posterior wall isolation. Before completion of the procedure, electrical isolation of the pulmonary veins will be confirmed. Thereafter, anticoagulation therapy and rhythm follow-up will be performed according to the study protocol.
干预措施: Pulmonary Vein Isolation (Procedure)
Pulmonary Vein Isolation (PVI) only Group
Pulmonary vein isolation (PVI) is performed as the primary procedure. After PVI, direct current (DC) cardioversion is performed to restore normal sinus rhythm. If the patient converts to sinus rhythm, they are randomly assigned to either the PVI-only group or the additional left atrial posterior wall ablation group. Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization. Patients assigned to this group after successful conversion to normal sinus rhythm by electrical cardioversion following PVI will undergo no additional left atrial posterior wall isolation. Before completion of the procedure, electrical isolation of the pulmonary veins will be confirmed. Thereafter, anticoagulation therapy and rhythm follow-up will be performed according to the study protocol.
干预措施: Non-PV trigger test (Procedure)
结局指标
主要结局
Recurrence of atrial tachyarrhythmia
时间窗: Within one year from the time of enrollment, excluding the first three months after the procedure
Clinical recurrence rate of atrial fibrillation within one year after the procedure.
Recurrence of atrial tachyarrhythmia
时间窗: Within 12 months after the procedure, excluding the first 4-week blanking period
Freedom from documented AF/AT/AFL ≥30 seconds at 12 months post-procedure
次要结局
- Peri-procedural complication(Within one year from the time of enrollment)
- Total procedure time(Periprocedural)
- Length of hospital stay(Within one year from the time of enrollment)
- patient satisfaction(Within one year from the time of enrollment)
- Atrial fibrillation burden(Within one year from the time of enrollment)
- Peri-procedural complication(Within 12 months after the procedure)
- Atrial fibrillation burden assessed by Holter ECG(Within 12 month from the time of enrollment)