Antiarrhythmics or Ablation for Ventricular Tachycardia 2
Antiarrhythmics or Ablation for Ventricular Tachycardia 2
A multicenter, randomized clinical trial to assess 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 (VT).
Implantable Defibrillators (ICDs) reduce sudden death and can terminate some VT without
 shocks, but they don't prevent VT; the most appropriate strategy to suppress VT remains
 unknown. Two randomized clinical trials have suggested that catheter ablation can
 significantly reduce the incidence of subsequent VT in patients after an initial episode.
 Neither trial, however, compared catheter ablation to active antiarrhythmic drug therapy.
 Randomized trials of antiarrhythmic drug therapy have demonstrated that therapy with either
 sotalol or amiodarone can reduce recurrent VT. Both antiarrhythmic drug and ablation therapy
 suffer from imperfect efficacy and the potential for significant side-effects. No study has
 compared ablation to drug therapy for first-line treatment. The VANISH study which compared
 ablation to aggressive antiarrhythmic drug therapy for patients who have failed initial drug
 therapy was published in May 2016, and demonstrated that for patients with drug-refractory
 VT, catheter ablation was superior to escalation of antiarrhythmic drug therapy. Benefits
 were seen in the group which had VT despite amiodarone. Event rates were similar between
 amiodarone and sotalol for patients with VT occurring despite sotalol, who were randomized to
 either new initiation of amiodarone or catheter ablation. These results do not address the
 clinical question of the most appropriate first line therapy for suppression of VT in persons
 with prior myocardial infarction, an ICD and VT.

 The trial hypothesis is: catheter ablation will, in comparison to antiarrhythmic drug therapy
 reduce 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
 below the detection rate of the ICD for patients with prior myocardial infarction and
 sustained monomorphic ventricular tachycardia.
Inclusion Criteria:

 -  Prior Myocardial Infarction and

 -  One of the following VT events while not being treated with amiodarone, sotalol, or
 another class I or class III antiarrhythmic drug) within the last 6 months:

 -  Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by
 pharmacologic means or DC cardioversion

 -  ≥3 episodes of VT treated with antitachycardia pacing (ATP), at least one of
 which was symptomatic

 -  ≥ 5 episodes of VT treated with antitachycardia pacing (ATP) regardless of
 symptoms

 -  ≥1 appropriate ICD shocks,

 -  ≥3 VT episodes within 24 hours

 Exclusion Criteria:

 -  Unable or unwilling to provide informed consent.

 -  Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST
 segment changes demonstrated on ECG) or another reversible cause of VT (e.g.
 drug-induced arrhythmia), had recent acute coronary syndrome within 30 days, coronary
 revascularization (<90 days bypass surgery, <30 days percutaneous coronary
 intervention), or have CCS functional class IV angina. Note that biomarker level
 elevation alone after ventricular arrhythmias does not denote acute coronary syndrome
 or active ischemia.

 -  Are ineligible to take the antiarrhythmic drug to which they would be assigned due to
 allergy, intolerance or contraindication

 -  Are known to have protruding left ventricular thrombus or mechanical aortic and mitral
 valves

 -  Have had a prior catheter ablation procedure for VT

 -  Are in renal failure (Creatinine clearance <15 mL/min), have NYHA Functional class IV
 heart failure, or a systemic illness likely to limit survival to <1 year

 -  Have had recent ST elevation myocardial infarction or non-ST elevation MI (< 30 days);
 note that biomarker elevation alone after ventricular arrhythmias does not denote MI.

 -  Are pregnant.