Trial to Evaluate the Efficacy and Safety of Substrate Ablation of Monomorphic Ventricular Tachycardia

Randomized Controlled Phase IV Multicentric Trial, Comparing the Efficacy and Safety of Radiofrequency Substrate Ablation of Monomorphic Ventricular Tachycardia vs. Antiarrhyhtmic Drugs in Patients Experiencing Appropriate ICD Shocks

To compare the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia.

Sustained monomorphic ventricular tachycardia remains an important source of morbidity and mortality in patients surviving a myocardial infarction. ICD´s have been proven to reduce mortality in this patients population, nonetheless, recurrent arrhythmia and ICD shocks are known to negatively impact ventricular function and are associated with worsening heart failure and mortality. We devised a controlled, randomized, parallel, single blind, phase IV clinical trial with the aim of comparing the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia, implanted with an ICD.

Inclusion Criteria:

• Ischemic cardiomyopathy, with ischemic myocardial scar
• Sustained monomorphic ventricular tachycardia
• Age > 18 years
• Prior ICD implantation

Exclusion Criteria:

• VT storm
• NYHA functional class IV
• Additional indication for antiarrhythmic drug therapy
• Contraindication for both study drugs (amiodarone and sotalol).
• Uncontrolled myocardial ischemia.
• LV thrombus.
• Non-ischemic VT substrate.
• Contraindications for anticoagulation.
• Prior substrate ablation in the previous 6 months
• Cr > 2.5 mg/dL
• Mitral AND aortic mechanical valvular prosthesis