Objective
This trial evaluates whether catheter ablation, compared to antiarrhythmic drug therapy, reduces the composite outcome of death at any time, appropriate ICD shock after 14 days, ventricular tachycardia storm after 14 days, or treated sustained ventricular tachycardia, for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia.
Background
Implantable defibrillators (ICDs) reduce sudden death and can terminate some VT without shocks, but they do not prevent VT, and the most appropriate strategy to suppress VT remains unknown. The original VANISH study, published in 2016, demonstrated that for patients with drug-refractory VT, catheter ablation was superior to escalation of antiarrhythmic drug therapy. However, no study has compared ablation to drug therapy for first-line treatment. VANISH-2 addresses the critical question of the most appropriate first-line therapy for patients with VT, as emerging evidence suggests that early treatment may result in significantly better outcomes.
Study Outcomes
Primary
- Determine whether catheter ablation or antiarrhythmic drug therapy provides the most effective control of important clinical outcomes for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia
Secondary
- All-cause mortality
- Appropriate antitachycardia pacing from ICD at any time or after 14 days
- Ventricular tachycardia storm at any time or after 14 days
- Sustained VT not treated by ICD at any time or after 14 days
- Sustained VT treated with appropriate external/internal/manual/pharmacologic conversion
- Inappropriate ICD shocks at any time or after 14 days
- Any ICD shock at any time or after 14 days
- Quality of life
- Cost-effectiveness
Eligibility Criteria
The criteria below are a summary. Your study doctor will confirm whether this study is right for you.
Inclusion Criteria
- Prior myocardial infarction (Q waves or imaging evidence of regional myocardial akinesis/thinning with documented prior ischemic injury), AND
- One of the following monomorphic VT events within the last 6 months while not on amiodarone, sotalol, or another Class I/III antiarrhythmic: sustained monomorphic VT, > 3 episodes of monomorphic VT, > 5 episodes of monomorphic VT, > 1 appropriate ICD shock, or > 3 monomorphic VT episodes within 24 hours
Exclusion Criteria
- Unable or unwilling to provide informed consent
- Active ischemia or another reversible cause of VT, recent acute coronary syndrome within 30 days, or CCS class IV angina
- Ineligible for the assigned antiarrhythmic drug due to allergy, intolerance, or contraindication
- Known protruding left ventricular thrombus or mechanical aortic and mitral valves
- Prior catheter ablation procedure for VT
- Presenting arrhythmia of polymorphic VT or ventricular fibrillation
- Renal failure (CrCl < 15 mL/min), NYHA class IV heart failure, or systemic illness likely limiting survival to < 1 year
- Pregnancy
About taking part
If you would like to learn more about taking part in this study, please contact our research team using the details on this page. We can walk you through what participation involves and answer any questions.