NCT07122336招募中不适用
Optimized Ablation of the Posterior Wall in Persistent Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 384
- 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 three randomized groups：（1）PVI group；（2）PVI+PWI group;（3）PVI+PWI+EGM 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
- •Age ≥18 years
- •First-time ablation for persistent atrial fibrillation (PsAF)
- •Persistent AF definition: Sustained episodes lasting ≥7 days but ≤3 years (including episodes requiring pharmacologic or electrical cardioversion after ≥7 days)
- •Symptomatic AF with intolerance to at least one antiarrhythmic drug (AAD)
- •Documented PsAF episode: At least one recorded PsAF episode within the last 2 years prior to enrollment, confirmed by: ECG,Holter monitorin, Loop recorder, Telemetry, Transtelephonic monitoring (TTM),Implantable device
- •Ability and willingness to provide written informed consent
- •Compliance with all study follow-up requirements
排除标准
- •Paroxysmal AF: Episodes lasting <7 days (or requiring pharmacologic/electrical cardioversion <7 days)
- •Long-standing persistent AF: Continuous AF duration >3 years
- •No prior attempt/pursuit of cardioversion or sinus rhythm maintenance
- •Contraindications to systemic anticoagulation
- •Advanced renal or hepatic failure
- •Severe valvular heart disease or cyanotic congenital heart disease
- •Hypertrophic cardiomyopathy (HCM)
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 any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure(12 months)
- The atrial fibrillation burden among study groups at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs.(12 months)
- Freedom from any documented atrial arrhythmia episodes lasting >30 seconds at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs (AADs)(12 months)
- freedom from any documented symptomatic atrial fibrillation/flutter/tachycardia episodes (>30 seconds) after assessment of all ablation procedures at final follow-up, excluding the initial 3-month blanking period.(12 months)
- Procedure time / Fluoroscopy time / ablation time(12 months)
- Periprocedural complications, including stroke, pulmonary vein stenosis, cardiac perforation, esophageal injury, and mortality.(12 months)
- Freedom from any documented sustained atrial arrhythmia episodes lasting >7 days at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without antiarrhythmic drug therapy(12 months)
- Quality of life assessments during ≥12-month follow-up (AFEQT)(12 months)
研究者
Xu Liu
Doctor Liu
Shanghai Chest Hospital
研究点 (1)
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