EUCTR2009-011790-32-NL进行中（未招募）不适用
Catheter ablation versus Amiodarone to prevent future shock episodes in patients with a defibrillator and a history of a myocardial infarction. - CARFE
Isala Klinieken Department Cardiology0 个研究点目标入组 310 人开始时间: 2009年3月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 310
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 polymophic 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 what can be treated by revascularisation
- •b.Whenever VT or VF occurs in the setting of antiarrhythmic medication intake (class I or III Vaughn-William) with increased QTc, the patient will not be a candidate for enrolment.
- •c.High fever (T>39 degrees Celcius) and signs of infection/sepsis at presentation will exclude patient from enrolment
- •d.Lead dislocation on X-ray plus signs of mechanical VT induction will exclude patients from the study
- •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
- •The contribution of electrolyte abnormalities to an episode of unstable VT is notoriously difficult to ascertain, especially if the abnormal electrolyte level is noted after cardiopulmonary resuscitation. In view of this fact, abnormal electrolyte levels will not be used in assessing eligibility for enrollment.
- •Although volume overload due to heart failure is a possible trigger for VT/VF, it can also be caused by an episode of VT/VF. Therefore, this will not be marked as a reversible cause. If, however, the patient is not successfully treated for the episode of volume overload, he can be excluded from the study. This decision will be at the discretion of the attending physician.
- •Patients with a cluster of VTs (electrical storm) who require urgent RF ablation are not a suitable candidates for our study. Whether these patients require urgent intervention, will be left at the discretion of the investigator. These patients will be registered.
- •4.Optimal revascularization before ICD implantation performed
- •5.Written informed consent
- •Patients who meet the inclusion and exclusion criteria and sign the informed consent will be considered enrolled in the study. No patient will be enrolled without an informed consent document signed by the patient. Informed consent forms have to be in compliance with the latest Declaration of Helsinki.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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 ½T 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 left ventricle.
- •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
- •18.Other disease process likely to limit survival to less than 12 months
- •19.lack of availability for follow-up
研究者
相似试验
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.Heart rythm disturbances / ICD shocks1000752110007593NL-OMON33105Diagram BV238
已完成
4 期
Catheter ablation versus Amiodarone to pRevent Future ventricular tachycardia Episodes in patients with a defibrillator and a history of a myocardial infarctioHeart rythm disturbances /ICD shocks1000752110043413NL-OMON35926Diagram B.V.116
进行中（未招募）
不适用
Catheter ablation versus Amiodarone to pRevent Future ventricular tachycardia Episodes in patients with a defibrillator and a history of a myocardial infarction - CARFE 2EUCTR2011-001141-32-NLIsala klinieken department Cardiology
暂停
不适用
Catheter ablation versus Amiodarone to pRevent Future ventricular tachycardia Episodes in patients with a defibrillator and a history of a myocardial infarction.Myocardial infarction, ICD Therapy, sustained VTNL-OMON21395Isala Klinieken, Locatie Weezenlanden, Department of Cardiology116
已完成
不适用
Pulmonary Vein Ablation versus Amiodarone in the ElderlyPalpitations10007521atrial fibrillationNL-OMON39450St. Jude Medical135