arrhythmia ventricular arrhythmia ventricular tachycardia
Conditions
Interventions
Group 1- Aggressive Antiarrhythmic Drug therapy. Patients randomized to
aggressive antiarrhythmic drug therapy will be treated with amiodarone or
amiodarone plus mexiletine.
Group 2- Catheter Ablat
Sponsors
The Queen Elizabeth II Health Sciences Centre
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)73 2. An implantable defibrillator 3. One of the following VT events (within last 3 months): A: *3 episodes of symptomatic VT treated with antitachycardia pacing (ATP), B: *1 appropriate ICD shocks, C: *3 VT episodes within 24 hr D: sustained VT below detection rate of the ICD documented by ECG/cardiac monitor 4. *Failed* first-line antiarrhythmic drug therapy (Class 1 or 3) as defined by one of: A: Appropriate ICD therapy or sustained VT occurred while the patient was taking amiodarone (patient on a stable dose for * 2 weeks) B: Appropriate ICD therapy or sustained VT occurred on another antiarrhythmic drug (patient on a stable dose for * 2 weeks)
Exclusion criteria
Exclusion criteria: 1. Are unable or unwilling to provide informed consent. 2. Have an acute coronary syndrome (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. electrolyte abnormalities, drug-induced arrhythmia) 3. Are known to be ineligible to take amiodarone, e.g. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy. 4. Are ineligible for ablation (known to have protruding left ventricular thrombus, or have implanted mechanical aortic and mitral valves) 5. Are in renal failure (Creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be a composite of death, appropriate ICD shock and VT storm. Shocks and storm during a 1 month post-randomization treatment period will be considered as secondary endpoints. Patients will be followed up for a minimum of 3 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include the following: all cause mortality, appropriate ICD antitachycardia pacing anytime and after 1 month treatment period, appropriate ICD shocks anytime and after 1 month treatment period, VT storm anytime and after 1 month treatment period, documented sustained VT below detection rate of the ICD any time and after 1 month treatment period, inappropriate shocks anytime and after 1 month treatment period, number of ICD shocks, hospital admission for cardiac causes, procedural complications, amiodarone toxicity or adverse events, effects on ejection fraction, quality of life/anxiety and cost-effectiveness. | — |
Countries
Netherlands
Outcome results
None listed