Catheter Ablation of Advanced Forms of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Atrial arrhythmia recurrence
研究概览
简要总结
The purpose of this study is to evaluate feasibility, safety, and efficacy of pulmonary vein isolation combined with posterior left atrial isolation and multiple linear lesions in both atria in patients with persistent and long-standing persistent atrial fibrillation.
详细描述
Patients with long-standing and persistent atrial fibrillation with severely dilated left atrium will undergo pulmonary vein isolation, box-lesion set of posterior wall, lateral mitral line (Marshall vein ablation and coronary sinus ablation per operator's discretion, anterior line, cavotricuspid line, superior caval vein isolation, intercaval line and inferior septal line. Ablations will be performed with either radiofrequency energy or pulsed field ablation at operator's discretion. Block at each line will be checked at the end of the procedure. The procedure will be performed with compliance of producer recommendation and hospital protocol.
All patients will be invited back at three months after index procedure for an invasive remap. At the remap procedure, pulmonary veins and posterior wall will be checked for isolation and all the additional lines will be checked for conduction block. Any gaps in lines will be ablated per operator's discretion.
Patients will undergo a period follow-up visit at 3, 6, and 12-month period. They will undergo a medical history taking, physical examination, ECG, and 7-day Holter ECG. Any documented atrial arrhythmia lasting more than 30 seconds after 8 week blanking period will be documented as a recurrence of atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persistent atrial fibrillation or long-standing persistent atrial fibrillation
- •severely enlarged left atrium (LAVI above 50 ml/m2)
排除标准
- •contraindications for electroporation
- •contraindications for general anaesthesia
- •age above 80 years
- •less than 1 year life expectancy
- •thrombus formation in left atrium
- •acute life-threatening disease
- •severe valvular disease requiring intervention
- •previous ablation in left atrium
- •secondary atrial fibrillation
研究组 & 干预措施
Cohort
Long-standing and persistent atrial fibrillation undergoing catheter ablation mimicking cox-maze procedure
干预措施: Endovascular ablation set mimicking cox maze 4 procedure. (Device)
结局指标
主要结局
Atrial arrhythmia recurrence
时间窗: 12 months
Atrial fibrillation/atrial tachycardia/atrial undulation lasting more than 30s after 8 week blanking period and without antiarrhythmic drug therapy. Assessed with 7-day Holter ECG at 3, 6, 12 months after index procedure.
次要结局
- Efficacy of endovascular Cox maze procedure(12 month)
- Interventions(12 months)
- Durability of ablation lines and isolations(3 months)
- Safety of catheter ablation procedure(6 months)
研究者
Matevz Jan
Principle Investigator
University Medical Centre Ljubljana