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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEFA targeted substrate ablation | Experimental | Use of PEFA strategy to identify and target VT isthmuses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEFA VT ablation technique | Procedure | Catheter ablation guided by PEFA technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | a composite of death - any time post procedure myocardial infarction and sustained ventricular tachycardia or fibrillation. | 3 years |
| Appropriate ICD shock | Time to first appropriate ICD shock - any time post procedure | 3 years |
| VT storm | Time to 3 or more episodes of VT within 24 hours - any time post procedure | 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 | 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 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Appropriate anti-tachycardia pacing (ATP) from ICD | Appropriate anti-tachycardia pacing (ATP) from ICD - any time post procedure | 3 years |
| Inducible for ventricular arrhythmia | Number of inducible for ventricular arrhythmia following catheter ablation guided by PEFA protocol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmitry Uchitel | Contact | 613-533-2148 | dmitry.uchitel@kingstonhsc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Damian Redfearn, MD | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston Health Sciences Centre | Recruiting | Kingston | Ontario | K7L 2V7 | Canada |
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This is a Canadian multi-centre prospective cohort study of 40 participants.
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| 3 years |
| 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 | 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 | 3 years |
| London Health Sciences Centre | Not yet recruiting | London | Ontario | N6A 5A5 | Canada |
|
| University of Ottawa Heart Institutation | Not yet recruiting | Ottawa | Ontario | Canada |
|