Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach

Study Overview
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Brief Summary
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Rationale: Nowadays ventricular tachycardia (VT) ablation in structural heart disease is performed primarily by early referral; while at the same time we still struggle with the limited longterm ablation success of endocardial VT ablation. An underestimated number of VTs from ischemic substrate have an epicardial exit. However, one cannot accurately predict who is in need of epicardial ablation. The investigators hypothesise endo/epicardial substrate homogenization in a first approach to be superior to endocardial substrate homogenization alone, in terms of recurrence on follow-up. Objective: To show superiority of a combined endo/epicardial approach compared to a stepwise approach in the ablation of ventricular tachycardia in a population with ischemic cardiomyopathy on VT recurrence. Study design: Multicenter prospective open randomized controlled trial. Study population: All patients above 18 years with an ischemic cardiomyopathy being referred for a ventricular tachycardia ablation. Intervention: One group undergoes endo/epicardial ablation and the other group has endocardial ablation only as a first approach. Main study parameters/endpoints: The main study endpoint is the difference in recurrences of ventricular tachycardia on follow-up - clinical or on implantable cardioverter defibrillator (ICD) interrogation - between the two ablation groups; secondary endpoints are procedure success and safety.

Official Title
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Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach a Randomized Controlled Trial

Conditions
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Ventricular Tachycardia, Ischemic Cardiomyopathy

Intervention / Treatment
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* Other: combined endo/epicardial approach
* Other: stepwise approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical indication for ablation of a monomorphic ventricular tachycardia referred to one of the participating ablation centers history of ischemic heart disease ICD carrier or ICD implantation planned after the ablation informed written consent Exclusion Criteria: current unstable angina as defined by current european guidelines AMI < 30 days or in case of incessant VT < 14 days absence of visualisation of the coronary anatomy (coronary angiogram /CT-angiogram) significant coronary stenosis approachable and clinically relevant for intervention presence of a mobile left ventricle thrombus seen on (contrast) echocardiography or MRI previous pericarditis presence of mitral/aortic mechanical valves prosthesis; previous coronary artery bypass graft; any other thoracic surgery that could cause pericardial adhesions previous thoracic radiation therapy contra-indication for general anaesthesia age below 18 years

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combined endo/epicardial approach<br>combining endocardial scar homogenization with epicardial scar homogenization in the first VT ablation approach | Other: combined endo/epicardial approach<br> <br> * Other names: endo /epicardial catheter ablation;|
| Active Comparator: stepwise approach<br>endocardial scar homogenization only at the first VT ablation procedure | Other: stepwise approach<br>* endocardial scar homogenization only at the first VT ablation procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence (Recurrence of any ventricular tachycardia) | Recurrence of any ventricular tachycardia: any appropriate ICD therapy or VT > 30 seconds of duration recorded by ICD interrogations or on clinical event recorded by electrocardiogram with an initial blanking period of 1 week after the ablation procedure | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure success | success: non-inducibility of any sustained monomorphic VT partial success: non-inducibility of clinical VT (inducibility of non-clinical VT excluding polymorphic VT, VT with cycle length < 200ms) | 2 years | 
| procedure related (serious) adverse events | major: death, acute myocardial infarction (AMI) / coronary artery damage, major bleeding - type III and V, abdominal bleeding, tamponade > 80cm3, late tamponade, ischemic cerebral event minor: dry right ventricle puncture, drainable hemopericardium, postprocedural precordial pain, phrenic nerve injury, minor bleeding - type II | 30 days | 
| procedure time, fluoroscopy and radiofrequency time |  | one day | 
| time to recurrence to ventricular arrhythmia |  | 2 years | 
| number of appropriate ICD therapy on follow-up |  | 2 years | 
| number of ventricular arrhythmia related hospitalizations |  | 2 years | 
| free of antiarrhythmic drugs on follow-up |  | 2 years | 
| repeat procedure |  | 2 years | 
| incessant VT or VT storm on follow-up |  | 2 years | 
| mortality |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epicardial catheter ablation