Ventricular Tachycardia
Conditions
Keywords
Ventricular tachycardia, Catheter ablation, Epicardial ablation, arrhythmia recurrence
Brief summary
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
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.
Interventions
PROCEDUREEndocardial ablation
Endocardial ablation of VT
PROCEDUREEndocardial- Epicardial ablation
Epicardial ablation of VT in addition to endocardial ablation
DRUGAntiarrhythmic medications
Addition of anti arrhythmic medication or dose increase
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the ablation procedures and medications treatment assignment, physicians and patients cannot be blinded to the randomization.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from documented VT episodes | 12 months | Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication. |
| Freedom from documented VT episodes after second intervention | 12 months 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of repeat procedures | 12, 24 months | Number of repeat ablations |
| Incidence of peri-procedural and 12-month post procedural complications, | 12 months | These complications include but not limited to ischemic stroke, cardiac perforation, rehospitalization, and death. |
| Long-term follow-up to evaluate freedom of documented VT episodes | 24 and 60 months | Long-term follow-up at 24 and 60 months to evaluate freedom of documented VT episodes (\>30 seconds) |
| Cost-effectiveness analysis | 12 months | 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. |
| Procedure duration and fluoroscopy time | Up to 4 hours (During ablation procedure) | Procedure duration and fluoroscopy time |
Countries
United States
Outcome results
None listed