Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias. A Prospective, Randomized Multicentre Study.
Overview
- Phase
- Phase 4
- Intervention
- Radiofrequency catheter ablation
- Conditions
- Myocardial Infarction
- Sponsor
- Central Finland Hospital District
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Radiofrequency catheter ablation
Radiofrequency catheter ablation using open-irrigated ablation catheter and 3D electroanatomical mapping
Intervention: Radiofrequency catheter ablation
Antiarrhythmic drug therapy
Amiodarone (or sotalol) tablet by mouth for the duration of the study
Intervention: Antiarrhythmic drug therapy
Outcomes
Primary Outcomes
Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes
Time Frame: 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 Outcomes
- 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)