This study aims to compare antiarrhythmic drug therapy with catheter ablation using the SmartTOUCH catheter (Biosense Webster Inc.) as treatment for patients with ventricular tachycardia and coronary artery disease
This is a multicenter, randomized prospective cohort study to compare the impact of catheter ablation with antiarrhythmic drug therapy for treating patients with sustained ventricular tachycardia (VT) and coronary artery disease. Patients that meet all inclusion criteria and no exclusion criteria will be recruited to the study cohort. After baseline measurements are taken, patients will be randomized in a 2:1 fashion to either undergo radiofrequency catheter ablation or receive antiarrhythmic drug therapy (amiodarone or sotalol). The in-clinic appointments include: enrollment, baseline, intervention, and follow-up every three months for one year post-ablation. At each follow-up visit, electrogram (ECG) and Holter monitoring tests will be performed to measure any episodes of ventricular tachyarrhythmia. Furthermore, interrogation of the patient's implantable cardioverter defibrillator (ICD) will be performed at all follow-up visits to detect any episodes of ventricular tachyarrhythmia that required antitachycardia pacing (ATP) or shocks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Catheter ablation of ventricular tachycardia will employ three-dimensional mapping Fast Anatomical Mapping or CARTOSOUND technology (Biosense Webster Inc.), and the Thermocool Navistar catheter (Biosense Webster Inc.).
Patients will be tiered to one of two possible antiarrhythmic drugs (sotalol or amiodarone).
Recurrence of Ventricular Tachycardia
Number of any appropriate ATPs/shocks and/or presentations of sustained (\>30sec) VT on Holter or ECG recording at 3, 6, 9 and 12 months after intervention
Time frame: 1 year
Time to First Shock/ATP for VT or to First Presentation of Sustained VT
Change in time to first ATP/shock or presentation of sustained (\>30sec) VT on Holter or ECG recording at 3, 6, 9 and 12 months after intervention
Time frame: 1 year
Total mortality
Change in mortality status at 3, 6, 9 and 12 months after intervention
Time frame: 1 year
Sudden cardiac death
Change in sudden cardiac death status at 3, 6, 9 and 12 months after intervention
Time frame: 1 year
Syncope
Change in syncope status at 3, 6, 9 and 12 months after intervention
Time frame: 1 year
Number of hospitalizations
Change in number of hospitalizations at 3, 6, 9 and 12 months after intervention
Time frame: 1 year
QOL measures
Change in QOL measures at 6 and 12 months after intervention
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.