Efficacy of High Density Voltage and Fractionation Map Guided Ablation Compared to Anatomy-based Circumferential Pulmonary Vein Isolation in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Free from atrial arrhythmia at 12 months
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of high density voltage and fractionation map guided ablation compared to anatomy-based circumferential pulmonary vein Isolation in patients with atrial fibrillation
详细描述
In this study, a test group includes those who undergoing atrial fibrillation(AF) ablation guided by high density voltage and fractionation map. A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential pulmonary vein (PV) isolation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 20 years old and under 80 years old
- •Patients with non-valvular atrial fibrillation
- •Patients having AF even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
- •Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them
- •Patients who are available of follow-up at least for more than three months after catheter ablation
排除标准
- •Patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm
- •Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
- •Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
- •Patients in the subject group vulnerable to clinical study
- •Patients who had undergone a prior catheter ablation for atrial fibrillation
研究组 & 干预措施
High density voltage and fractionation map guided group
- Complex fractionated atrial electrogram (CFAE), voltage and fractionation map will be performed with a multielectrode mapping catheter.
- The mapping should be performed in AF.
- First, low-voltage zone is defined as an area with bipolar peak-to-peak voltage amplitudes < 0.5mV.
- A voltage-map guided segmental PV isolation is performed. Radiofrequency energy is applied in the antral regions of the PVs. High voltage zone over 0.5mV in the antral region is targeted. IF PV isolation in not achieved by voltage-guided segmental ablation, additional Lasso catheter guided segmental antral ablation is performed.
- Radiofrequency energy is delivered at target sites for 15-30 sec guided by contact force, lesion size index (LSI) and local electrogram elimination.
- If the patient is still in AF after PV isolation, additional fractionation map guided ablation is performed. The fractionation area within low voltage area (<0.5mV) should be targeted.
干预措施: AF ablation (Procedure)
Circumferential PV isolation
A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential PV isolation.
干预措施: AF ablation (Procedure)
结局指标
主要结局
Free from atrial arrhythmia at 12 months
时间窗: 12 months
Freedom from any atrial arrhythmia lasting longer than 30 seconds during 1 year follow-up after single ablation with or without the use of antiarrhythmic medications with the exclusion of the 3-month blanking period.
次要结局
- Acute AF termination rate during the procedure(During the procedure)
- Complication rate(12 months)
- Total procedure time, ablation time, fluoroscopy time(12 months)