Canadian multicentre prospective cohort study of 40 patients with ischaemic heart disease and therapy from an implantable cardioverter defibrillator (ICD).
Paced Electrogram Feature Analysis is employed to elucidate VT isthmus sites and target Type I sites for ablation to prevent recurrent VT/VF. The trial hypothesis is: catheter ablation employing PEFA will, in comparison to published data, reduce the composite outcome of death at any time, appropriate ICD shock, ventricular tachycardia storm or treated sustained ventricular tachycardia below the detection rate of the ICD or incessant VT for patients with prior myocardial infarction and sustained ventricular tachycardia or fibrillation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Catheter ablation guided by PEFA technique
Kingston Health Sciences Centre
Kingston, Ontario, Canada
RECRUITINGLondon Health Sciences Centre
London, Ontario, Canada
NOT_YET_RECRUITINGUniversity of Ottawa Heart Institutation
Ottawa, Ontario, Canada
NOT_YET_RECRUITINGAll-cause mortality
a composite of death - any time post procedure myocardial infarction and sustained ventricular tachycardia or fibrillation.
Time frame: 3 years
Appropriate ICD shock
Time to first appropriate ICD shock - any time post procedure
Time frame: 3 years
VT storm
Time to 3 or more episodes of VT within 24 hours - any time post procedure
Time frame: 3 years
Treated sustained VT below the detection rate of the ICD
Time to any sustained VT below the detection rate of the ICD; e.g. by external cardioversion, pharmacologic conversion, or manual ICD therapy - any time post procedure
Time frame: 3 years
Incessant VT
Time to incessant VT defined as a sustained ventricular arrhythmia which does not terminate despite appropriate external cardioversion/defibrillation or ICD antitachycardia pacing or shocks, or terminates but reinitiates within ≤5 seconds - any time post procedure
Time frame: 3 years
Appropriate anti-tachycardia pacing (ATP) from ICD
Appropriate anti-tachycardia pacing (ATP) from ICD - any time post procedure
Time frame: 3 years
Inducible for ventricular arrhythmia
Number of inducible for ventricular arrhythmia following catheter ablation guided by PEFA protocol
Time frame: 3 years
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Number of ventricular arrhythmia events
This is a composite of appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion, and incessant VT - any time during or after the procedure
Time frame: 3 years
Escalation and De-escalation of antiarrhythmic medication
Any increase or decrease in the dosage of antiarrhythmic medication either due to inefficacy or side effects will be assessed - any time post procedure
Time frame: 3 years