Does VoltagE Guided Additional Ablation Improve Procedural Outcome of Atrial Fibrillation Ablation? (The VEGA-AF Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Freedom rate of any atrial tachy-arrhythmia during 1 year after ablation procedure
研究概览
简要总结
This study is designed to investigate whether pulmonary vein isolation(PVI) plus stepwise additional ablation approach based on the degree of low voltage area versus PVI only can improve procedure outcome in persistent atrial fibrillation(AF) patients.
详细描述
Catheter ablation of AF is well accepted and widely performing treatment method of AF at present. Pulmonary vein isolation (PVI) which aims to electrical isolation of pulmonary veins is currently the standard therapy for AF. But some researchers proposed additional ablation strategy for persistent AF (PeAF) because abnormal atrial substrate may play a role in these patients.
However, there are inconsistent reports regarding a success rate of additional catheter ablation methods other than PVI. Thus, there still is no consensus on which strategy is appropriate in addition to PVI. One of these proposed options is complex fractioned atrial electrograms (CFAE) ablation. A meta-analysis of controlled trials comparing PVI alone versus PVI with CFAE reported that the addition of CFAE ablation results in a statistically significant increase in success rate for PeAF patients. Conversely, a prospective multicenter trial, The Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II (STAR-AF II) trial showed that recurrence rate of AF following catheter ablation treatment was not significantly reduced when either linear ablation or ablation of CFAE was performed in addition to PVI. The investigators have previously reported that posterior wall isolation in addition to PVI plus linear lesions reduced recurrence of AF following catheter ablation compared to PVI only but the long-term success rate were markedly lower in the CFAE-guide ablation in addition PVI plus linear lesions group than in PVI plus linear lesions group among PeAF patients. Although benefit of addition CFAE could be originated from modification of abnormal atrial substrate which is generated by structural and electrical remodeling, this possible benefit could be counterbalanced by increased formation of transmural ablation scar which may result in dysfunction of left atrium and recurrence of atrial tachyarrhythmia. A recent study have showed that extent of myocardial injury by catheter ablation was associated with left atrium functional deterioration in patients with paroxysmal AF and myocardial damage provoked that may contribute to recurrence of AF following catheter ablation.
Therefore, identification of PeAF patients who would benefit from additional ablation and tailored stepwise approach based on the identification may lead to reduction of iatrogenic myocardial injury and optimization of the result for the AF catheter ablation.
Recent data have shown that voltage guided mapping of left atrium is a powerful predictor of AF recurrence after PAI and voltage based ablation strategy showed promising result in terms of tailored approach. But, prospective, randomized clinical studies are needed to compare the result of a voltage-based AF ablation to the result of established strategies.
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
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing first-time catheter ablation for AF.
- •Willing and able to provide informed consent
- •Age greater than or equal to 18 years.
排除标准
- •Patients who have previously undergone AF ablation
- •Patients with more than mild mitral valve stenosis or mechanical mitral valve replacement
- •Patients with chronic renal impairment with creatinine clearance rate of <30 mL/min
- •Patients who are pregnant
结局指标
主要结局
Freedom rate of any atrial tachy-arrhythmia during 1 year after ablation procedure
时间窗: Within 1 year after the ablation procedure
Any recurrence of ECG or Holter documented atrial tachyarrhythmia\* \* Sustained AF or atrial tachycardia \>30 s duration.
次要结局
- Procedure related complication rate(during procedure and follow-up period(up to 1 year))
- Total procedural time(During procedure)
研究者
Hong Euy Lim, MD
Professor
Korea University Guro Hospital
