Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in ischemic Ventricular Tachyarrhythmias. A prospective, randomized multicentre study MANTRA-VT - MANTRA-VT

Central Finland Hospital District0 个研究点目标入组 120 人开始时间: 2014年11月14日最近更新: 2014年12月1日

试验速览

暂无简介。

•Patients 18-80 years of age with prior myocardial infarction and ICD or ICD with biventricular pacing capability (CRT-D) for primary or secondary prevention of sudden cardiac death (SCD), who have had at least two documented episodes of sustained VT or VF and no chronic amiodarone treatment for ventricular tachyarrhythmias, are eligible to participate in the study. The last VT/VF episode should be documented in the foregoing 12 months either ECG or by the device. All patients will give written informed consent for the study before randomization.
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•Age less than 18 years or more than 80 years
•Non-ischemic cardiomyopathy
•Ongoing chronic treatment of ventricular tachyarrhytmias with amiodarone
•Intolerance/contraindication to all class III antiarrhythmic drugs (i.e., intolerance/contraindication to one class III agents is not excluding the patient if another one can be used)
•Contraindication to endocardial catheter ablation (e.g., intracavitary thrombi, contraindication to perioperative anticoagulation)
•Previous VT/VF ablation
•Open heart surgery within 3 months
•Prosthetic heart valve
•Planned revascularization (PCI or CABG), surgery for structural heart disease or heart transplantation
•Pregnancy or planned pregnancy within the follow-up period
•Secondary cause for VT/VF (e.g., acute myocardial infarction)
•Patient does not want to participate
•Life expectancy less than 12 months

发起方

Central Finland Hospital District