NL-OMON48860已完成不适用
Elimination of ventricular premature beats and ventricular tachycardia with catheter ablation versus optimal anti-arrhythmic drug treatment - ECTOPIA
Maatschap Cardiologie Zwolle0 个研究点目标入组 180 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
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
- •-Patients willing and capable to provide written informed consent
- •- Patients with frequent symptomatic VPB/VT and/or nonsustained VTs with a
- •burden of * 5% AND
- •-Absence of structural heart disease AND
- •-Absence of underlying cardiac ischemia AND
- •-Patient is considered an acceptable candidate for catheter ablation treatment
- •dominant morphology of VPB/VT origin judged by the treating physician.
- •-For those already undergoing treatment, all antiarrhythmic drugs including
- •digitalis must be discontinued during a 2- week washout period before entry to
排除标准
- •-Age >75 years
- •- Previous catheter ablation therapy for VPB/VT
- •-Patients with sustained ventricular tachycardia or cardiac channelopathies
- •(e.g. CPVT, long- or short QT syndrome, Brugada syndrome)
- •-WPW syndrome
- •- Use of medication with risk of QTc prolongation (e.g. antidepressant,
- •antiemetic), except for study medication sotalol.
- •- Left ventricular dysfunction (LV ejection fraction <55%)
- •-Estimated glomerular filtration rate < 50 ml/min/1.73 m2
- •-Hepatic impairment defined by a total bilirubin * 2 times the upper limit
- •(ULN) of normal ALAT or ASAT * 3 times ULN at screening.
- •-Untreated hypo- or hyperthyroidism or electrolyte imbalance
- •- Untreated obstructive sleep apnea
- •-Patients with history of myocardial infarction or bypass surgery
- •- More than grade 1/3 valvular regurgitation and/or significant valve stenosis
- •(moderate or severe)
- •- Contraindication for any of the antiarrhythmic drugs used in this study
- •- Enrolment in another trial
- •- Woman currently pregnant or breastfeeding or not using reliable contraceptive
- •measures during fertile age
- •- Mental or physical inability to participate in the study
- •-Life expectancy * 12 months
研究者
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