Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia

Study Overview
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Brief Summary
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Canadian multicentre prospective cohort study of 40 patients with ischaemic heart disease and therapy from an implantable cardioverter defibrillator (ICD).

Detailed Description
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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.

Official Title
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Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia

Conditions
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Ischemic Ventricular Tachycardia (VT)

Intervention / Treatment
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* Procedure: PEFA VT ablation technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: greater than 18 years of age Ischaemic heart disease and prior myocardial infarction (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause with documentation of prior ischaemic injury) Eligible for catheter ablation as standard of care Implantable Cardioverter Defibrillator Exclusion Criteria: Unable or unwilling to provide consent Both mechanical aortic and mitral valve LV thrombus, NYHA class IV heart failure symptoms Contraindication to heparin Survival limited to <1 year in estimation of attending care team, Prior VT ablation Exclusion to standard of care VT catheter ablation procedure such as Active ischaemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug- induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia. Non-ischaemic cardiomyopathy because of reduced ablation success and PEFA has not been examined in the context of a non-ischaemic cardiomyopathy

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a Canadian multi-centre prospective cohort study of 40 participants.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEFA targeted substrate ablation<br>Use of PEFA strategy to identify and target VT isthmuses. | Procedure: PEFA VT ablation technique<br>* Catheter ablation guided by PEFA technique<br>* Other names: Paced electrogram feature analysis or 'PEFA';|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |