NL-OMON33105已完成4 期
Catheter ablation versus Amiodarone to prevent future shock episodes in patients with a defibrillator and a history of a myocardial infarction. - CARFE
Diagram BV0 个研究点目标入组 238 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 238
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. prior myocardial infarction, at least 3 months ago
- •2. ICD implantation for any cause except for: Brugada sy, ARVC, HCM, LQTS, SQTS, cathecholaminergic polymorphic VT, other channelopathies
- •3. ICD shock for VT of VF without a reversible cause
- •reversible causes (must be checked):
- •a. Acute myocardial ischemia in the following circumstances:
- •i. Acute coronary syndrome
- •ii. Myocardial ischemia as documented by non-invasive myocardial ischemia testing
- •b. Whenever VT or VF occurs in the setting of antiarrhythmic medication intake (class I or III Vaughn-William) with increased QTc
- •c. High fever (T>39 degrees Celcius) and signs of infection/sepsis at presentation
- •d. Lead dislocation on X-ray plus signs of mechanical VT induction
- •e. Other reversible causes as significant hypoxaemia not caused by cardiac failure or known hyperthyroidism. Judgement whether this will be possible cause of VT/VF will be at discretion of the attending physician
- •4. Optimal revascularization before ICD implantation performed
- •5. Written informed consent
排除标准
- •Exclusion criteria
- •1. Age < 18 years
- •2. use of amiodarone more than 7 days before randomization within the period of 3 months before randomization
- •3. unability to use amiodarone due to past side effects
- •4. Class I antiarrythmic drugs not stopped <= 5 times *T prior to randomization
- •5. Protruding LV thrombus or cardiac tumor on pre-ablation echocardiogram
- •6. Acute myocardial infarction within the preceding 3 months
- •7. non-reversible Class IV NYHA heart failure
- •8. Valvular heart disease or mechanical heart valve precluding access to the LV.
- •9. Unstable coronary artery syndrome or active myocardial infarction
- •10. Cardiac surgery within the past 2 months
- •11. mechanical mitral or tricuspid valve prothesis
- •12. Serum creatinine > 220 mmol/L (2.5 mg/dL)
- •13. Thrombocytopenia or coagulopathy
- •14. Contraindication to anticoagulation
- •15. stroke within past 30 days
- •16. Pregnancy
- •17. Acute illness or serious active systemic infection
研究者
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