Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy

Study Overview
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Brief Summary
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This is a prospective multicenter randomized open-label study aiming to assess whether endocardial or endocardial-epicardial ablation is superior to the standard approach (i.e., Antiarrhythmic drugs) in achievement of long-term ventricular tachycardia (VT) treatment success.

Detailed Description
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Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy (EPI VT) is a prospective multicenter randomized controlled study that is planned as a pilot study to include 100 patients. The aim of our study is to assess whether endocardial or endocardial-epicardial ablation is superior to the standard approach (i.e., Antiarrhythmic drugs) in the achievement of long-term ventricular tachycardia (VT) treatment success. Patients will be stratified into two groups depending on the history of taking antiarrhythmic medications (AAD) and each group will be further randomized 1:1 for endocardial and epicardial ablation vs endocardial only ablation in group who failed AAD. And in the group who didn't fail AADs patients will be randomized 1:1:1 into 3 groups: endocardial and epicardial ablation, endocardial only ablation or antiarrhythmic medications. Follow up planned at 3, 6 and 12 months, if VT recurrence is noted, repeated procedure (according to initially allocated group) or adjustment of medications (if AAD group) will be performed. Follow up at 3, 6 and 12 months is also planned after a repeat procedure/ medications adjustment. Primary endpoints include freedom from documented VT episodes (> 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication and freedom from documented VT episodes (>30 seconds) at 12 months after the second ablation procedure or on two antiarrhythmics combined.

Official Title
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Endocardial-Epicardial Radiofrequency Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Procedure: Endocardial ablation
* Procedure: Endocardial- Epicardial ablation
* Drug: Antiarrhythmic medications


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 18 or greater Patient with ≥ 1 episode of VT (i.e., Sustained VT more than 30 seconds or VT with any ICD therapy) Patients with ischemic cardiomyopathy, EF less than 50%, documented history of CAD Exclusion Criteria: Patients with ventricular fibrillation. Reversible causes of VT. Patients with contraindications to systemic anticoagulation with heparin or coumadin, direct thrombin inhibitor or factor Xa inhibitors. Patients with prior procedure involving opening the pericardium or entering the pericardial space (e.g., CABG, heart transplantation, valve surgery) were adhesions are suspected Any prior ablation for the ventricles or any prior epicardial ablation Documented history of myocardial infarction within 1 month prior to the planned study intervention Documented symptomatic carotid disease defined as > 70% stenosis or > 50% stenosis with symptoms Any history of thoracic radiation with the exception of localized radiation treatment for breast cancer Active pericarditis Active endocarditis\Any documented history or autoimmune disease associated with pericarditis Thrombocytopenia (platelet count < 100 x 109/L) Body Mass Index (BMI > 45) Patients who are pregnant. Pregnancy will be assessed by urine pregnancy testing prior to the ablation procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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
Interventional Model Description: A total of 100 patients will be randomized in 1:1 fashion to investigation arms Endocardial - Epicardial (20 patients) or Endocardial ablation (20 patients) if patients have previously failed AAD and in 1:1:1 fashion randomization to Endocardial - Epicardial ablation (20 patients), Endocardial ablation (20 patients) and AAD (20 patients) if patients have not failed AAD previously. If during follow up VT recurrence occurs, treatment method that patient was assigned to will be considered failed and patients will undergo redo ablation (same as previously assigned to) or if AAD failed patient will be added a second AAD or changed to another AAD. If during follow up after second procedure or adjustment of AAD patient experiences VT recurrence the treatment method will be considered failed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients who didn't fail AAD<br>This group of patients will be randomized to 3 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation; 3) Antiarrhythmic medications | Procedure: Endocardial ablation<br>* Endocardial ablation of VT<br>Procedure: Endocardial- Epicardial ablation<br>* Epicardial ablation of VT in addition to endocardial ablation<br>Drug: Antiarrhythmic medications<br>* Addition of anti arrhythmic medication or dose increase<br>|
| Active Comparator: Patients who failed AAD<br>This group of patients will be randomized to 2 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation | Procedure: Endocardial ablation<br>* Endocardial ablation of VT<br>Procedure: Endocardial- Epicardial ablation<br>* Epicardial ablation of VT in addition to endocardial ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from documented VT episodes | Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication. | 12 months | 
| Freedom from documented VT episodes after second intervention | Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the second ablation procedure or on two antiarrhythmics combined. | 12 months after second intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of peri-procedural and 12-month post procedural complications, | These complications include but not limited to ischemic stroke, cardiac perforation, rehospitalization, and death. | 12 months | 
| Procedure duration and fluoroscopy time | Procedure duration and fluoroscopy time | Up to 4 hours (During ablation procedure) | 
| Number of repeat procedures | Number of repeat ablations | 12, 24 months | 
| Cost-effectiveness analysis | The CEA will examine the cost of health care resources and health outcomes from the ablation procedure to 1-year postoperatively. The costs will include all health care utilization during this time. Health care utilization, and associated costs, related to the patients' condition, the procedure and adverse events will be the basis of a sensitivity analysis. | 12 months | 
| Long-term follow-up to evaluate freedom of documented VT episodes | Long-term follow-up at 24 and 60 months to evaluate freedom of documented VT episodes (>30 seconds) | 24 and 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter ablation, Ventricular tachycardia, Epicardial ablation, arrhythmia recurrence