Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias

Phase 4

• Conditions: Myocardial Infarction; Ventricular Tachyarrhythmia
• Interventions: Drug: Antiarrhythmic drug therapy; Procedure: Radiofrequency catheter ablation

• Registration Number: NCT02303639
• Lead Sponsor: Central Finland Hospital District

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-11-21
• Study First Submitted QC: 2014-11-28
• Study First Posted: 2014-12-01
• Study Start: 2015-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-01
• Primary Completion: 2017-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antiarrhythmic drug therapy	Antiarrhythmic drug therapy	Amiodarone (or sotalol) tablet by mouth for the duration of the study
Radiofrequency catheter ablation	Radiofrequency catheter ablation	Radiofrequency catheter ablation using open-irrigated ablation catheter and 3D electroanatomical mapping

Primary Outcome Measures

Name	Time	Method
Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes	12 months	• Number of appropriate ICD therapies (defibrillation, cardioversion, antitachycardia pacing) for VT/VF and otherwise documented sustained VT or VF episodes at 12 months

Secondary Outcome Measures

Name	Time	Method
All cause mortality	12 and 24 months
Number of electrical storm episodes	12 and 24 months
Number of inappropriate ICD therapies	up to 24 months
Cardiovascular mortality	12 and 24 months
Time to first hospitalization and number of hospital days	12 and 24 months
Time to reablation	up to 24 months
Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires	12 and 24 months
Number of non-sustained VT episodes	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
Time to first VT/VF	up to 24 months
Number of atrial fibrillation and other supraventricular arrhythmia episodes	up to 24 months
Number of appropriate ICD therapies and sustained VT/VF episodes	24 months

Trial Locations

Locations (2)

Central Finland Central Hospital; 🇫🇮 Jyväskylä, Finland

Heart Center Tampere University Hospital; 🇫🇮 Tampere, Finland