Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy
Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy
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.
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.
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.

 1. Pregnancy will be assessed by urine pregnancy testing prior to the ablation
 procedure