NCT01780311Unknown4 期
Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 试验地点
- 1
- 主要终点
- SF-36 score
研究概览
简要总结
A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs for outflow tract ventricular arrhythmias
研究设计
- 研究类型
- Interventional
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
- •presence of ventricular ectopic beats (VEB) with left-bundle-branch block morphology or right-bundle-branch block morphology and positive concordance throughout the chest leads, inferior axis and at least one of the following:
- •>2000 isolated VEB/24h
- •symptomatic monomorphic ventricular tachycardia
- •left ventricular disfunction supposed to be due to tachycardia-induced cardiomyopathy
排除标准
- •known structural heart disease
- •life expectancy < 1 year
研究组 & 干预措施
Antiarrhythmic drugs
Active Comparator
Flecainide or Propafenone or Sotalol (oral, standard dosage)
干预措施: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol) (Drug)
ABLATION
Experimental
Catheter Ablation
干预措施: Catheter Ablation (Procedure)
结局指标
主要结局
SF-36 score
时间窗: 6 months
Quality of life improvement according to SF-36 score variations
次要结局
未报告次要终点
研究者
Leonardo Bolognese, MD
Director
Ospedale San Donato
研究点 (1)
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