Ventricular tachyarrhtyhmias in patients with prior myocardial infarction and implantable cardioverter defibrillator MedDRA version: 17.1 Level: LLT Classification code 10007518 Term: Cardiac arrhythmia System Organ Class: 100000004849
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Central Finland Hospital District
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to evaluate whether catheter based ablation is superior to optimized antiarrhythmic medical therapy in preventing recurrent VT/VF episodes among patients with ischemic heart disease and implantable cardioverter defibrillator (ICD) who are not already using chronic antiarrhythmic medication. ;Secondary Objective: Secondary objectives include evaluation of the impact of the therapies on mortality, hospitalization for cardiac reason, health economics, quality of life and several ICD and arrhythmia related issues.;Primary end point(s): Number of appropriate ICD therapies (defibrillation, cardioversion, antitachycardia pacing) for VT/VF and otherwise documented sustained VT or VF episodes at 12 months.;Timepoint(s) of evaluation of this end point: The primary end point will be evaluated at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All cause mortality Cardiovascular mortality Hospitalization (cause, time to first hospitalization, length of hospitalizations) Ablation/antiarrhythmic medication related side effects including proarrhythmic events Health economics (including planned and unplanned hospitalization and out patients visits, (type, length and number of antiarrhythmic drugs) Quality of life (SF-36, EQ 5D) Patient related outcome Number of appropriate ICD therapies and documented sustained VT or VF episodes at 24 months Number of non-sustained VTs detected by the device Incidence of electric storm Time to first VT/VF episode Time to reablation or change of antiarrhythmic medication (i.e., crossover) Efficacy of ICD therapies Inappropriate ICD therapies Incidence of atrial fibrillation and other sustained supraventricular tachyarrhythmias ;Timepoint(s) of evaluation of this end point: Secondary end points will be evaluated at 12 and 24 months. | — |
Countries
Denmark, Finland, United States
Contacts
Public ContactMANTRA-VT / Cardiology
Central Finland Hospital District
Outcome results
None listed