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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
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.
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
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Appropriate ICD shocks,VT storm and death
Time frame: 3 years
All cause mortality
Time frame: 3 years
Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period
Time frame: 3 years
appropriate ICD shocks anytime and after 1 month treatment period
Time frame: 3 years
Inappropriate shocks anytime and after 1 month treatment period
Time frame: 3 years
VT storm anytime and after 1 month treatment period
Time frame: 3 years
Documented sustained VT below detection rate of the ICD any time and after 1 month treatment period
Time frame: 3 years
Number of ICD shocks
Time frame: 3 years
Hospital admission for cardiac causes
Time frame: 3 years
Procedural complications, amiodarone toxicity or adverse events
Time frame: 3 years
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