Prospective Randomized Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 498
- 试验地点
- 12
- 主要终点
- The recurrence rate of atrial tachycardia arrhythmias
研究概览
简要总结
Catheter ablation has emerged as an important treatment option for patients with symptomatic atrial fibrillation (AF). Pulmonary vein antral isolation (PVI) is now considered the cornerstone technique of AF ablation and has shown promise in treating paroxysmal atrial fibrillation (PAF). However, there is no unique strategy for ablation of persistent AF (PeAF), whether PVI alone is sufficient to prevent patients from recurrence remains controversial. The PROMPT-AF study is a prospective, multicenter, randomized trial involving a blinded assessment of outcomes, which is designed to compare arrhythmia-free survival between PVI and an ablation strategy termed upgraded '2C3L' for ablation of PeAF.
详细描述
The PROMPT-AF study will include 498 patients undergoing their first catheter ablation of PeAF. All patients will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1 fashion. The upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM, bilateral circumferential PVI, and three linear ablation lesion sets across the mitral isthmus, left atrial roof, and cavotricuspid isthmus. The follow-up duration is 12 months. The primary endpoint is the rate of documented atrial tachycardia arrhythmias of >30 seconds, without any antiarrhythmic drugs, in 12 months after the index ablation procedure (excluding a blanking period of 3 months).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all the following criteria to be included in the study:
- •age between 18 and 80,
- •patients undergoing a first-time ablation procedure for non-valvular AF,
- •patients with defined as a sustained episode more than 3 months
- •PeAF documented by ECG, Holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within 90 days6 months of the ablation procedure,
- •patients experienced symptoms caused by AF and these symptoms include but are not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath,
- •AF refractory to at least one AAD,
- •willingness, ability and commitment to provide informed consent and participate in follow-up evaluations.
排除标准
- •Patients are to be excluded if any of the following criteria is met：
- •patients with paroxysmal AF,
- •patients with AF secondary to an obvious reversible cause,
- •patients with left atrial diameter ≥ 60 mm in the parasternal long axis view,
- •left ventricular ejection fraction (LVEF) < 30%,
- •patients with triple (aspirin, clopidogrel and OAC) or dual (clopidogrel and OAC) antithrombotic therapy which predispose patients to higher risk of periprocedural bleeding. (e.g., Coronary percutaneous transluminal coronary angioplasty (PTCA)/stenting within the previous 90 days),
- •patients with contraindication to anticoagulation,
- •patients with contraindication to right or left sided heart catheterization,
- •life expectancy less than 1 year (advanced malignant tumor, end stage renal disease, etc.),
- •patients cannot be removed from antiarrhythmic drugs for reasons other than AF.
研究组 & 干预措施
Upgraded '2C3L'
Patients randomized to the upgraded '2C3L' arm will first undergo ethanol infusion in the vein of Marshall (EI-VOM) followed by the '2C3L' ablation step which includes bilateral circumferential PV antral ablation and linear ablations across the left atrial roof, mitral isthmus (MI), and cavotricuspid isthmus (CTI).
干预措施: upgraded '2C3L' (Procedure)
Pulmonary vein antral isolation (PVI)
Patients randomized to the PVI arm will undergo right PV antrum ablation, followed by the left PVA ablation. Radiofrequency should be applied 1 cm proximal to the PV ostia in a wide-area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished.
干预措施: pulmonary vein antral isolation (Procedure)
结局指标
主要结局
The recurrence rate of atrial tachycardia arrhythmias
时间窗: 1 year
freedom from any documented atrial arrhythmia after a 3-months post-ablation blanking period, including AF, AT, and AFL, for more than 30 seconds in the absence of antiarrhythmic drug (AAD) therapy.
次要结局
- Freedom from AF/AT off AADs(1 year)
- Freedom from AF/AT with or without AADs(1 year)
- AFEQT score change between baseline and 12 month(1 year)
- Freedom from AF off AADs(1 year)
- AF burden(1 year)
- Freedom from AF/AT after multiple procedures(1 year)
- EQ5D score change between baseline and 12 month(1 year)
- Incidence of procedural complications(Within 1 month after the procedure)
研究者
Chang sheng Ma
Director of Cardiology
Beijing Anzhen Hospital