Comparison of Pulmonary Vein Isolation With and Without Transitional Zone Modification in Atrial Fibrillation Patients Without Low-Voltage Areas
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 162
- 主要终点
- Freedom From AF and/or ATs With or Without Antiarrhythmic Drugs (AADs)
研究概览
简要总结
This study investigates two treatments for atrial fibrillation (AF) patients without low-voltage-areas (LVAs). It aims to determine whether adding transition zone modification (TZM) to the pulmonary vein isolation (PVI) improves long-term outcomes compared to PVI alone.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Follow-up physicians are blinded to treatment allocation
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
- 否
入选标准
- •Aged 18 to 80 years AF referring for ablation No prior history of AF Absence of low-voltage areas during substrate mapping Presence of transition zone during substrate mapping Sign informed consent
排除标准
- •Presence of left atrial thrombus Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease Untreated hypothyroidism or hyperthyroidism Dialysis-dependent terminal renal failure Life expectancy <12 months due to non-cardiovascular causes. Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study Female under pregnancy or breast-feeding Involved in other studies
研究组 & 干预措施
Active Comparator: PVI-alone arm
干预措施: Pulmonary vein isolation alone (Procedure)
Experimental: PVI+TZM arm
干预措施: Pulmonary vein isolation plus transition zone modification (Procedure)
结局指标
主要结局
Freedom From AF and/or ATs With or Without Antiarrhythmic Drugs (AADs)
时间窗: at least 12 months follow up
Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each episode lasts \> 30 seconds.
次要结局
- Incidence of Peri-procedural Complications(1 week after patient enrollment)
- Total procedure time(1 week after patient enrollment)
- Total fluoroscopic time(1 week after patient enrollment)
- Total RF delivery time(1 week after patient enrollment)
研究者
Minglong Chen
Dr.
The First Affiliated Hospital with Nanjing Medical University