A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint Versus Prespecified Ablation Strategy Followed by Cardioversion in Patients With Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period
研究概览
简要总结
This is a prospective, randomized, multi-center trial that aims to investigate whether termination of atrial fibrillation can be used as an ablation endpoint for persistent atrial fibrillation (PersAF). Eligible patients who provided consent were randomly assigned to one of two groups: the AF-termination group (whose ablation endpoint was the pursuit of AF-termination) or the prespecified-ablation group (whose ablation endpoint was prespecified ablation followed by electrical cardioversion).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Age 18-80 years old.
- •. Patients undergoing a first-time ablation procedure for PersAF.
- •. Diagnosed as persistent AF according to the latest clinical guidelines.
- •. Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment.
- •. Patients must be able and willing to provide written informed consent to participate in this study.
排除标准
- •. Uncontrolled congestive heart failure;
- •. History of severe valve disease and/or prosthetic valve replacement;
- •. Myocardial infarction or stroke within 6 months;
- •. Severe congenital heart disease;
- •. EF <35%;
- •. Contrast agent allergy;
- •. The use of anticoagulant drugs is contraindicated;
- •. Severe lung disease;
- •. Left atrial thrombus confirmed by preoperative esophageal ultrasound;
- •. Contraindications for cardiac catheterization;
- •. Prior left atrial ablation (surgical or catheter);
- •. Have performed any cardiac surgery within 2 months;
- •. Poor general health;
- •. Life expectancy < 12 months.
结局指标
主要结局
freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period
时间窗: Time Frame: 12 months
All patients included in the study had no incidence of Atrial fibrillation (AF), atrial tachycardia (AT) or Atrial flutter (AFL) at 12 months after ablation, excluding the initial 3-month blank period
次要结局
- freedom from AF/AT after a single procedure without AADs (excludes the blanking period)(Time Frame: 12 months)
- freedom from AF/AT after a single procedure with or without anti-arrhythmic medications (excludes the blanking period)(Time Frame: 12 months)
- any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment(Time Frame: 12 months)
- procedural details(Time Frame: 12 months)
- freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure(Time Frame: 12 months)
- incidence of periprocedural adverse events(Time Frame: 12 months)
研究者
Xu Liu
Principal Investigator
Shanghai Chest Hospital