NCT06837441已完成不适用
Atrial Fibrillation Termination Versus Prespecified Ablation for Persistent Atrial Fibrillation:A Pilot Study
适应症
干预措施
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.-
研究组 & 干预措施
AF-termination group
Experimental
干预措施: Atrial Fibrillation Termination (Procedure)
Prespecified-ablation group
Sham Comparator
干预措施: Prespecified Ablation (Procedure)
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)
Loading locations...
相似试验
已完成
不适用
Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided ProceduresPersistent Atrial FibrillationNCT02274857Abbott Medical Devices350
已完成
4 期
Rate Control in Atrial Fibrillation IIPermanent Atrial FibrillationAtrial FibrillationNCT02695992Asker & Baerum Hospital122
Unknown
4 期
Line Versus Spot Ablation in Persistent Atrial FibrillationAtrial FibrillationNCT00196157Deutsches Herzzentrum Muenchen116
撤回
不适用
Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical FlutterTypical Atrial FlutterRisk Factors With Future Development of Atrial FlutterNCT01710150University of Pennsylvania
已完成
3 期
Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)Cardiovascular DiseasesHeart DiseasesArrhythmiaAtrial FibrillationNCT00000556National Heart, Lung, and Blood Institute (NHLBI)