NCT07095959招募中不适用
Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation
Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2025年7月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period
研究概览
简要总结
The Marvel-PAF trial is an investigator initiated, multi-center, open-label, randomized trial, which aims to compare the effectiveness of vein of Marshall in addition to pulmonary vein isolation using pulsed field ablation in the treatment of paroxysmal atrial fibrillation. The primary endpoint is any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period.
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 (Outcomes Assessor)
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 over 18 years;
- •With symptomatic* paroxysmal AF;
- •Undergoing first AF ablation;
- •At least one AF lasting over 30s documented by 12-lead ECG, Holter, or other rhythm monitoring device in the past 12 months;
- •Able to understand the purpose of the study, willing to receive randomization of the ablation strategy, and able to be followed up as required, voluntarily participate in the study and signed a written informed consent.
- •Symptoms include but not restricted to palpitations, dizziness, fatigue, or shortness of breath and chest discomfort
排除标准
- •Diagnosed with persistent atrial fibrillation or duration of atrial fibrillation >7 days;
- •Thrombosis in the heart cavity;
- •Contraindications to oral anticoagulants including the presence of a history of heparin-induced thrombocytopenia;
- •Transient/reversible atrial fibrillation due to electrolyte disorders, thyroid disease or other non-cardiac-related causes;
- •Acute coronary syndrome in the past 3 months or coronary intervention or coronary artery bypass treatment;
- •Stroke or transient ischemic attacks (TIA) in the past 3 months;
- •History of cardiac surgery or other surgical history involving left atrium, such as previous left atrial catheter ablation, atrial septal defect repair, etc.;
- •History of previous severe valvular disease (severe mitral stenosis or regurgitation), congenital heart disease, hypertrophic cardiomyopathy or dilated cardiomyopathy;
- •TEE examination in the past 12 months showed that the left atrium diameter of the parasternal long axis section was ≥55mm;
- •Other factors that are not suitable for surgery (such as history of organ transplant surgery or ongoing evaluation of organ transplant surgery, life expectancy less than 1 year, uncontrolled cancer, pregnancy, breastfeeding, or planning to get pregnant, etc.);
- •Other patients who were not suitable for enrollment in this study after the investigator's evaluation;
结局指标
主要结局
Any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period
时间窗: 12 months after procedure excluding the 2-month blanking period
次要结局
- Any atrial arrhythmias lasting ≥30s with or without AAD during 12 months after procedure excluding the 2-months blanking period(12 months after procedure excluding the 2-months blanking period)
- Any atrial flutter/atrial tachycardia lasting ≥30s during 12 months after procedure excluding the 2-months blanking period(12 months after procedure excluding the 2-months blanking period)
- Any atrial arrhythmias after multiple ablation with or without AADs(12 months after first procedure excluding the 2-months blanking period)
- AF burden(12 months after procedure excluding the 2-months blanking period)
- procedural complications(30 days after the procedure)
- Change in quality of life(at baseline and 12 months after procedure)
研究者
Caihua Sang
Executive director of Arrhythmia center
Beijing Anzhen Hospital
研究点 (1)
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