Comparison between treatment with catheter ablation or anti-arrhythmic drugs (sotalol or combination of verapamil and flecainide) of patients with benign ventricular premature beats and ventricular tachycardia; a prospective, randomized, multicenter trial - ECTOPIA

Maatschap Cardiologie Zwolle0 个研究点目标入组 180 人开始时间: 2018年8月1日最近更新: 2022年5月2日

适应症

试验速览

暂无简介。

•-Patients willing and capable to provide written informed consent
•-Patients with frequent symptomatic VPB/VT and/or nonsustained VTs with a burden of = 5% on 24 hour Holter monitor AND
•-Absence of structural heart disease AND
•-Absence of underlying cardiac ischemia AND
•-Patient is considered an acceptable candidate for catheter ablation treatment with a
•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 the study
•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 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

•-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)
•- ontraindication for any of the antiarrhythmic drugs used in this study
•- Enrolment in another clinical study
•- 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

发起方

Maatschap Cardiologie Zwolle