NCT06837441已完成不适用
Atrial Fibrillation Termination Versus Prespecified Ablation for Persistent Atrial Fibrillation:A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 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, at a minimum of 12 months follow up after a single ablat
研究概览
简要总结
The design of this study is an intervention, randomized, controlled study and contains two randomized groups：（1）AF-termination group；（2）Prespecified-ablation group.
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
- 是
入选标准
- •aged between 18 and 80 years old;
- •Patients undergoing a first-time ablation procedure for PersAF, and in spontaneous AF at the beginning of the procedure;
- •Diagnosed as persistent AF according to the latest clinical guidelines，with atrial fibrillation lasting for at least one month;
- •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;
- •Patients must be willing and able to comply with all study follow- up requirements.
排除标准
- •.Uncontrolled congestive heart failure, EF <35%;
- •. History of severe valve disease and/or prosthetic valve replacement;
- •. Myocardial infarction or stroke within 6 months;
- •. Severe congenital heart disease;
- •. Left atrial diameter ≥60mm;
- •. 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, including factors such as physical inability to tolerate ablation or unstable disease conditions.-
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, at a minimum of 12 months follow up after a single ablat
时间窗: 12 months
次要结局
- Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months；(12 months)
- Freedom from AF/AT/AFL after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months(12 months)
- Freedom from AF after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months(12 months)
- Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure(12 months)
- Incidence of periprocedural adverse events.(12 months)
研究者
Xu Liu
Doctor Liu
Shanghai Chest Hospital
研究点 (1)
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