Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT)

Study Overview
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Brief Summary
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Radiofrequency ablation of ventricular tachycardias (VTs) is the gold standard treatment of refractory VTs in patients with ischaemic heart disease. In this setting, ablation is usually performed endocardially. However, even after a procedural success there is a high risk of recurrence, particularly due to the inability to create transmural lesions. Indeed, only the endocardium of the LV has been ablated, while a significant part of the arrhythmia substrate may be located on the other side of the myocardial thickness, on the epicardial side of the LV. First described in 1996, epicardial ablation, performed via a percutaneous subxyphoid approach, has since undergone considerable development. Electrophysiologists often use a double endo- and epicardial approach as first line therapy for the ablation of VTs complicating myocarditis or arrhythmogenic dysplasia of the right ventricle, where the substrate is most often epicardial. For VT in ischaemic heart disease, electrophysiologists perform endocardial ablation, and often perform epicardial ablation only after several endocardial failures. Several observational studies suggest that a combined endo- and epicardial approach as first line therapy is associated with a reduced risk of VT recurrence. Since recurrent VT in patients with ischaemic heart disease as a prognostic impact in terms of morbidity and mortality, it appears essential to optimise rhythm management by ablation, by offering a combined approach from the as first approach to reduce the risk of recurrences. The aim of our prospective, multicentre, controlled, randomized study is therefore to compare the rate of VT recurrence after ablation performed as first line therapy either by endocardial approach alone or by combined endo-epicardial approach.

Official Title
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Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients Withischemic Cardiomyopathy: a Randomized Controlled Study

Conditions
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Ischemic Cardiomyopathy, Catheter Ablation of Ventricular Tachycardia

Intervention / Treatment
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* Procedure: Endo-epicardial ablation
* Procedure: endocardial ablation only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age 1st radiofrequency ablation of VT complicating ischaemic heart disease Patients with an ICD and remote monitoring Having, for women of childbearing age, effective contraception until discharge from hospital Have given their free and informed consent in writing are affiliated to or have health insurance Exclusion Criteria: History of cardiac surgery compromising the epicardial approach (coronary artery bypas s grafting, valve replacements, or other surgeries that may have caused pericardial adhesions) Anticoagulant therapy that cannot be temporarily discontinued Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy History of pericarditis Previous thoracic radiotherapy Contraindication to general anaesthesia Pregnant or breastfeeding woman History of heparin-induced thrombocytopenia type 2 (as injection is required during the procedure) Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent

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: Endo-epicardial ablation<br> | Procedure: Endo-epicardial ablation<br>* Endo-epicardial ablation of ventricular tachycardia<br>|
| Active Comparator: endocardial ablation only<br> | Procedure: endocardial ablation only<br>* endocardial-only catheter ablation of ventricular tachycardia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival free from ventricular arrhythmia recurrence | Survival free from ventricular arrhythmia recurrence, defined as the time interval between the date of ablation and the date of first ventricular arrhythmia recurrence. Recurrence of ventricular arrhythmia is defined as the occurrence of appropriate ICD therapy or the occurrence of sustained VT/VF > 30 seconds The occurrence of the event and the date of the event will be obtained from the ICD interrogation. Patients without recurrence will be censored at the date of last ICD interrogation | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventricular arrhythmias treated | Number of ventricular arrhythmias treated by the defibrillator with shocks or bursts of antitachycardia pacing during follow-up or the occurrence of sustained VT/VF > 30 seconds. | up to 5 years | 
| Percentage of patients with recurrent ventricular arrhythmia | Percentage of patients with recurrent ventricular arrhythmia | up to 5 years | 
| Percentage of patients with a electrical storm | Electrical storm is defined as the occurrence of at least 3 appropriate therapies (antitachycardia pacing or shocks) delivered by the defibrillator within 24 hours. | up to 5 years | 
| Number of serious complications | Number of serious complications related to the procedure | up to 5 years | 
| Number of patients hospitalized for cardiovascular reasons | Number of patients hospitalized for cardiovascular reasons (i.e. heart failure, rhythm disorders) at 2 years | up to 2 years | 
| Number of patients requiring a redo ablation for ventricular arrhythmia | Number of patients requiring a redo ablation for ventricular arrhythmia | Up to 5 years | 
| mortality rate | 2-year mortality rate | Up to 2 years | 
| Number of patients in each group who are non-inducible at the end of the procedure | Number of patients in each group who are non-inducible at the end of the procedure (programmed ventricular stimulation negative) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic cardiomyopathy