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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Catheter ablation with an open-irrigated tip ablation catheter and 3D electroanatomical mapping
Amiodarone (or sotalol) for prevention of VT/VF relapses
Central Finland Central Hospital
Jyväskylä, Finland
RECRUITINGHeart Center Tampere University Hospital
Tampere, Finland
RECRUITINGNumber 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
Time frame: 12 months
All cause mortality
Time frame: 12 and 24 months
Cardiovascular mortality
Time frame: 12 and 24 months
Time to first hospitalization and number of hospital days
Time frame: 12 and 24 months
Comparative cost-effectiveness of the therapies
Time frame: 12 and 24 months
Quality of life measured By SF-36 and EQ5D questionnaires
Time frame: 12 and 24 months
Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires
Time frame: 12 and 24 months
Number of appropriate ICD therapies and sustained VT/VF episodes
Time frame: 24 months
Number of non-sustained VT episodes
Time frame: 12 and 24 months
Number of electrical storm episodes
Time frame: 12 and 24 months
Time to first VT/VF
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Time frame: up to 24 months
Time to reablation
Time frame: up to 24 months
Number of inappropriate ICD therapies
Time frame: up to 24 months
Number of atrial fibrillation and other supraventricular arrhythmia episodes
Time frame: up to 24 months