Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias (MANTRA-VT)

Central Finland Hospital District

Status and phase: Unknown; Phase 4

Conditions: Ventricular Tachyarrhythmia; Myocardial Infarction

Treatments: Drug: Antiarrhythmic drug therapy; Procedure: Radiofrequency catheter ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02303639

7U/2014

Details and patient eligibility

About

The study evaluates whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses in patients with ischemic heart disease and implantable cardioverter defibrillator.

Full description

The study is designed to evaluate whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses among patients with prior myocardial infarction and implantable cardioverter defibrillator (ICD). The patients have not been using using chronic antiarrhythmic medication. Primary end point is number of ICD therapies (defibrillations, cardioversions and antitachycardia pacing) and otherwise documented sustained ventricular tachycardia (duration more than 30 s or hemodynamically unstable ) or ventricular fibrillation episodes during 12 months follow-up period. Secondary end points include mortality, hospitalization for cardiac reason, health economics, quality of life and several ICD and arrhythmia related issues. Total length of the follow-up is at least two years.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18-80 years of age with prior myocardial infarction and ICD (single chamber, dual chamber 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

Exclusion criteria

• Age less than 18 years or more than 80 years
• Non-ischemic cardiomyopathy
• Ongoing chronic treatment of ventricular tachyarrhythmias 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Radiofrequency catheter ablation

Experimental group

Description:

Radiofrequency catheter ablation using open-irrigated ablation catheter and 3D electroanatomical mapping

Treatment:

Procedure: Radiofrequency catheter ablation

Antiarrhythmic drug therapy

Active Comparator group

Description:

Amiodarone (or sotalol) tablet by mouth for the duration of the study

Treatment:

Drug: Antiarrhythmic drug therapy