Ablation of Persistent Atrial Fibrillation Based on High Density Voltage Mapping and Complex Fractionated Atrial Electrogram
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 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 additional ablation targeting complex fractionated atrial electrogram area within low voltage zone identified by high resolution mapping in patients with persistent atrial fibrillation.
详细描述
Fifty patients with persistent atrial fibrillation will be randomized a 1:1 ratio to each group. A test group includes those who undergoing ablation targeting low voltage areas which contains complex fractionated trial electrogram in addition to pulmonary vein isolation and a control group includes who undergoing pulmonary vein isolation only.
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
- 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 atrial fibrillation 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
Low-Voltage & CFAE guided ablation
- Pulmonary isolation will be performed
- Complex fractionated atrial electrogram(CFAE) and voltage mapping will be performed if atrial fibrillation the patient is still in atrial fibrillation after pulmonary vein isolation
- CFAE and voltage mapping will be performed simultaneously using small electrode Pentaray® Catheter with CARTO®3 MEM version or CARTO®3 CONFIDENSE™
- Automatic characterization of CFAE signals will be performed with an CARTO® CFAE software module.
- CFAE areas within low voltage zone in the left atrium should be targeted first. If atrial fibrillation persist after left atrial ablation, target areas in the right atrium should be mapped and ablated. (Low-Voltage & CFAE guided ablation)
干预措施: pulmonary vein isolation (Procedure)
Low-Voltage & CFAE guided ablation
- Pulmonary isolation will be performed
- Complex fractionated atrial electrogram(CFAE) and voltage mapping will be performed if atrial fibrillation the patient is still in atrial fibrillation after pulmonary vein isolation
- CFAE and voltage mapping will be performed simultaneously using small electrode Pentaray® Catheter with CARTO®3 MEM version or CARTO®3 CONFIDENSE™
- Automatic characterization of CFAE signals will be performed with an CARTO® CFAE software module.
- CFAE areas within low voltage zone in the left atrium should be targeted first. If atrial fibrillation persist after left atrial ablation, target areas in the right atrium should be mapped and ablated. (Low-Voltage & CFAE guided ablation)
干预措施: Low-Voltage & CFAE guided ablation (Procedure)
PV Isolation Only
- Pulmonary vein isolation will be performed.
- Electrical cardioversion to sinus rhythm will be performed if the patient is still in atrial fibrillation after pulmonary vein isolation.
干预措施: pulmonary vein isolation (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
- Total procedure time, ablation time and fluoroscopy time(12 months)
- Complication rate(12 months)
研究者
Hyoung-Seob Park
Associate Professor
Keimyung University Dongsan Medical Center