Computed Tomogram Myocardial Thickness Map-Guided Pulmonary Vein Isolation vs. Empirical Pulmonary Vein Isolation in Pulse-Field Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF III)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Freedom from atrial arrhythmia recurrence
研究概览
简要总结
This is a prospective, multicenter, randomized controlled trial comparing CT-guided versus empirical pulsed field ablation (PFA) for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. The study investigates whether atrial wall thickness-based energy titration improves arrhythmia outcomes compared to standard empirical ablation using the PulseSelect™ system.
详细描述
Pulmonary vein isolation (PVI) using pulsed field ablation (PFA) is an effective and increasingly adopted strategy for the treatment of paroxysmal atrial fibrillation (AF). However, current empirical lesion protocols do not account for patient-specific anatomical variability, particularly atrial wall thickness, which may influence lesion durability. This randomized controlled trial aims to evaluate whether a CT-guided ablation strategy-using pre-procedural atrial wall thickness maps to titrate lesion application-can improve rhythm outcomes compared to standard empirical PFA. A total of 298 patients will be enrolled and randomized to either the CT-guided or empirical group, with follow-up over 12 months to assess freedom from atrial arrhythmia recurrence and procedure-related safety outcomes.
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
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with paroxysmal atrial fibrillation who is scheduled for ablation procedure and ≥19 and ≤80 years of age
- •Left atrium size < 50mm
- •paroxysmal atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
- •Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)
排除标准
- •Patients with persistent or permanent atrial fibrillation
- •Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
- •Patients with severe renal impairment or CT imaging difficulty using contrast media
- •Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
- •Patients with active internal bleeding
- •Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
- •Patients with valvular atrial fibrillation (mitral stenosis >grade 2, mechanical valve, mitral valvuloplasty)
- •Patients with a severe comorbid disease
- •Expected survival < 1 year
- •Drug addicts or alcoholics
- •Patients who cannot read the consent form (illiterates, foreigners, etc.)
- •Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study
研究组 & 干预措施
CT myocardial thickness map guided PV isolation group
干预措施: CT myocardial thickness map guided PV isolation group (Procedure)
Empirical PV isolation group
干预措施: Empirical PV isolation group (Procedure)
结局指标
主要结局
Freedom from atrial arrhythmia recurrence
时间窗: Within 1 year after 3 months of procedure
Any documented episode of AF, atrial flutter, or atrial tachycardia lasting ≥30 seconds after a 3-month blanking period.
次要结局
- Procedure-related cardiac complication rate(30 days after procedure)