Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy
Ventricular Tachycardia Ablation or Escalated aNtiarrhythmic Drugs in ISchemic Heart Disease
  • Phase

    Phase 4
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    mexiletine amiodarone ...
  • Study Participants

This study will compare aggressive antiarrhythmic therapy to catheter ablation for ventricular tachycardia in patients who have suffered prior myocardial infarction. The purpose of this study is to evaluate the optimal management of patients presenting with recurrent VT and receiving ICD therapy in spite of first-line antiarrhythmic drug therapy. The hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for recurrent VT.
This is a multicentre, parallel group, two arm, unblinded, randomized clinical trial to compare two management strategies for patients with ischemic heart disease and recurrent ICD therapy despite at least one antiarrhythmic drug. The primary endpoint will be a composite of appropriate ICD shocks or death.
Study Started
May 31
Primary Completion
Dec 31
Study Completion
Dec 31
Last Update
Jul 11

Procedure Catheter Ablation

Intracardiac electrode catheters are placed via central vasculature to identify myocardial scar, and surviving conduction channels within the scar which form the substrate for ventricular tachycardia. Radiofrequency energy is applied to these sites, interrupting the VT circuits.

  • Other names: VT Ablation

Drug Escalated Antiarrhythmic Therapy

Patients who have 'failed' antiarrhythmic therapy (except amiodarone) will be prescribed: Amiodarone 400 mg twice daily for 2 weeks, followed by 400 mg/day for 4 weeks, followed by 200 mg/day thereafter. Patients who 'failed' amiodarone (less than 300mg/day) will be prescribed: Amiodarone 400 mg three times a day for 2 weeks, followed by 400 mg/day for 1 week and 300 mg/day thereafter. Patients who 'failed' amiodarone (greater or equal to 300mg/day) will be prescribed: Amiodarone at the current dose with the addition of mexiletine 400 to 800 mg/day

  • Other names: Cordarone, Mexetil

Ventricular Tachycardia Ablation Active Comparator

Catheter ablation for Ventricular tachycardia will be performed within 14 days of randomization.

Escalated Antiarrhythmic Drug Therapy Active Comparator

Patients are prescribed a loading dose of amiodarone or the addition of mexiletine to their current anti-arrhythmic medication which is stratified by the dose and type of antiarrhymic medication at the time of the index arrhythmic event.


Inclusion Criteria:

Prior Myocardial Infarction
An implantable defibrillator

One of the following VT events (within the past 3 months):

greater than or equal to 3 episodes of symptomatic VT treated with ATP
greater than or equal to 1 appropriate ICD shock
greater than or equal to 3 VT episodes within 24 hours
sustained VT below detection rate of the ICD documented by ECG

"Failed" first-line antiarrhythmic drug therapy as defined by one of:

Appropriate ICD therapy or sustained VT occurred while patient was taking amiodarone (stable dose >/= 2 weeks)
Appropriate ICD therapy or sustained VT occurred on another antiarrhythmic drug (stable dose >/= 2 weeks)

Exclusion Criteria:

Active ischemia (acute thrombus, dynamic ST elevation on ECG) or another reversible cause of VT (eg. electrolyte abnormalities, drug induced arrhythmia)
Are known to be ineligible to take amiodarone (eg. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy)
Are ineligible for ablation (left ventricular thrombus, implanted mechanical aortic and mitral valves)
Renal Failure (creatinine clearance < 15 ml/min)
Current NYHA functional class IV heart failure or CCS Functional Class IV angina
Recent ST elevation myocardial infarction (< 1 month)
Recent coronary bypass surgery (< 3 mon) or recent PCI (< 1 mon)
prior ablation for ventricular tachycardia
A systemic illness likely to limit survival to < 1 year
Unable or unwilling to provide informed consent
No Results Posted