Pulsed-Field Ablation Vs. Radiofrequency Ablation CombIned with Vein of Marshall Ethanol Ablation on Mitral Isthmus Block and Clinical Outcomes in Persistent Atrial Fibrillation: the PRIME-AF Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 主要终点
- Immediate success rate of mitral isthmus ablation block
研究概览
简要总结
Atrial fibrillation (AF) is one of the most common clinical arrhythmias, and catheter ablation serves as a critical therapeutic approach. For persistent atrial fibrillation, several proposed ablation strategies-including the 2C3L technique, BOX lesion sets, and substrate modification-remain highly controversial regarding long-term success rates. Multiple studies suggest that linear ablation beyond pulmonary vein isolation (PVI) often fails to achieve durable block due to incomplete ablation lines, which significantly contributes to postoperative recurrence of atrial arrhythmias.
In recent years, electrophysiologists have explored various methods to improve mitral isthmus (MI) ablation, such as combined endo-epicardial ablation and radiofrequency ablation (RFA) combined with Marshall vein alcohol ablation. While RFA combined with anhydrous alcohol injection into the Marshall vein enhances MI block rates, it is associated with prolonged procedure time, unpredictable ablation zones, and higher complication risks (e.g., coronary artery spasm, pericarditis).
Pulsed field ablation (PFA), an emerging non-thermal ablation technology, offers potential advantages such as tissue selectivity, shorter procedure time, and fewer complications. Studies report that RFA achieves near 100% immediate block rates; however, there is a lack of sufficient comparative studies on the efficacy and safety between these two ablation approaches. This study aims to compare the clinical outcomes and safety profiles of PFA versus RFA combined with Marshall vein alcohol injection in patients with persistent AF.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent atrial fibrillation;
- •Ejection fraction >30%;
- •NYHA functional class I-III;
- •Left atrial diameter <55 mm on echocardiography;
- •Signed informed consent form;
排除标准
- •Pregnant or lactating women;
- •Patients with a life expectancy of less than 2 years due to non-cardiovascular factors;
- •Uncontrolled hyperthyroidism, severe liver or kidney dysfunction;
- •History of atrial fibrillation ablation;
- •History of heart transplantation, complex congenital heart disease, or rheumatic heart disease;
- •Contraindications to contrast agents, radiofrequency ablation, antiarrhythmic drugs, or anticoagulants;
- •Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular 8.accident within 12 weeks prior to enrollment;
- •9.Other conditions deemed unsuitable for participation by investigators; 10.Participation in other clinical trials.
结局指标
主要结局
Immediate success rate of mitral isthmus ablation block
时间窗: immediately after the procedure
Bidirectional MI block was confirmed by the following criteria: (1) proximal-to-distal CS activation pattern when pacing at the left lateral ridge; (2) longer SA interval at the left lateral ridge when pacing at the distal CS compared to pacing at the proximal CS
Mitral isthmus block rate
时间窗: 20 minutes after the procedure
Bidirectional MI block was confirmed by the following criteria: (1) proximal-to-distal CS activation pattern when pacing at the left lateral ridge; (2) longer SA interval at the left lateral ridge when pacing at the distal CS compared to pacing at the proximal CS
次要结局
- time of operation(immediately after the procedure)
- The incidence of atrial arrhythmias (tachycardia, atrial flutter, atrial fibrillation) over 30 seconds without antiarrhythmic drugs was followed up for 12 months.(1 year)
- complication(2 weeks after the procedure)
研究者
lingzhiyu
Director, Clinical Professor
The Second Affiliated Hospital of Chongqing Medical University