Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias. A Prospective, Randomized Multicentre Study.

Conditions
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Myocardial Infarction, Ventricular Tachyarrhythmia

Intervention / Treatment
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* Procedure: Radiofrequency catheter ablation
* Drug: Antiarrhythmic drug therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency catheter ablation<br>Radiofrequency catheter ablation using open-irrigated ablation catheter and 3D electroanatomical mapping | Procedure: Radiofrequency catheter ablation<br>* Catheter ablation with an open-irrigated tip ablation catheter and 3D electroanatomical mapping<br>|
| Active Comparator: Antiarrhythmic drug therapy<br>Amiodarone (or sotalol) tablet by mouth for the duration of the study | Drug: Antiarrhythmic drug therapy<br>* Amiodarone (or sotalol) for prevention of VT/VF relapses<br>* Other names: class III antiarrhyhtmic agents;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes | • Number of appropriate ICD therapies (defibrillation, cardioversion, antitachycardia pacing) for VT/VF and otherwise documented sustained VT or VF episodes at 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 12 and 24 months | 
| Cardiovascular mortality |  | 12 and 24 months | 
| Time to first hospitalization and number of hospital days |  | 12 and 24 months | 
| Comparative cost-effectiveness of the therapies |  | 12 and 24 months | 
| Quality of life measured By SF-36 and EQ5D questionnaires |  | 12 and 24 months | 
| Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires |  | 12 and 24 months | 
| Number of appropriate ICD therapies and sustained VT/VF episodes |  | 24 months | 
| Number of non-sustained VT episodes |  | 12 and 24 months | 
| Number of electrical storm episodes |  | 12 and 24 months | 
| Time to first VT/VF |  | up to 24 months | 
| Time to reablation |  | up to 24 months | 
| Number of inappropriate ICD therapies |  | up to 24 months | 
| Number of atrial fibrillation and other supraventricular arrhythmia episodes |  | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implantable cardioverter defibrillator, antiarrhythmic medication, catheter ablation