Ablation, Implantable Cardiac Defibrillator, Myocardial Infarction (MI), Ventricular Tachycardias
Conditions
Keywords
ventricular tachycardia, myocardial infarction, epicardial access, pericardial sac puncture, ablation, implantable cardioverter defibrillator
Brief summary
The EPISODE VT trial is designed to compare efficacy and safety of two modalities for interventional treatment - endocardial ablation and endo-epicardial ablation in a population of patients with post myocardial infarction (ICD 10 - I25.2) ventricular tachycardias (ICD 10 - I47.2), who are protected by an implantable cardioverter-defibrilator (ICD) and meet study inclusion criteria.
Detailed description
The EPISODE VT trial is designed to compare efficacy and safety of two modalities for interventional treatment - endocardial ablation and endo-epicardial ablation in a population of patients with post myocardial infarction (ICD 10 - I25.2) ventricular tachycardias (ICD 10 - I47.2), who are protected by an implantable cardioverter-defibrilator (ICD) and meet study inclusion criteria. Nowadays, most often ablation is performed using only endocardial approach. The rate of VT recurrences after such ablation may exceed 50%, which is largely due to the inability to remove all arrhythmogenic substrate. At the same time, in cases where all potentially arrhythmogenic substrate is removed, the immediate and long-term results are better, both in terms of recurrence and prognosis. Single reports on endo-epicardial ablation as the first-line therapy in patients with post-infarction VT indicate a higher efficacy of this approach compared to endocardial ablation. Similar conclusions emerge from meta-analyses. This is probably due to a more complete removal of the arrhythmogenic substrate located mainly in the epicardium or intramurally. In the endo-epicardial group pericardial sac puncture will be performed after filling it with carbon dioxide, which creates a space for safe puncture. Ablation procedures will be performed as standard. The electrophysiological systems and ablation electrodes used in the study will be standard devices that research centers are equipped with. Their use will be in accordance with the procedures of the center and the instructions for use.
Interventions
PROCEDUREEndocardial VT ablation
Post-myocardial infarction VT radiofrequency ablation using a standard endocardial approach
PROCEDUREEndo-epicardial VT ablation
Post-myocardial infarction VT radiofrequency ablation using an endo-epicardial approach with pericardial sac puncture preceded by CO2 insufflation
Sponsors
National Institute of Cardiology, Warsaw, Poland
Medical University of Warsaw
MEDICOVER SP Z O.O.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Status after myocardial infarction (minimum 3 months before inclusion in the study). * Documented post-infarction VT or VF. * Implantable ICD (at least 2 weeks before ablation) or CRT-D (at least 2 months before ablation). * A history of at least one from below: 1. One or more high energy interventions. 2. Three or more adequate antitachycardia pacing therapies, including one symptomatic. 3. Three or more episodes of VT in 24 hours (interrupted by ATP or shock) - electrical storm. 4. Sustained VT recorded on ECG with a cycle length longer than the ICD detection threshold. * Age between 18 and 85 years. * Signed informed consent to participate in the study.
Exclusion criteria
* Obesity with BMI \> 40 kg/m2. * Left ventricle ejection fraction \< 20%. * Pregnancy or breastfeeding. * Renal failure (eGFR \< 20 mL/min/1.73m2). * Fresh ballot thrombus in the left ventricle. * Suspicion of massive adhesions in the pericardium that may impede pericardial puncture. * Ablation of the post-infarction VT in the left ventricle in medical history. * Previous heart surgery. * Acute conditions that prevent ablation (including active infection, overt hyperthyroidism and others listed below). * Active neoplastic disease. * Heart failure with NYHA IV. * Life expectancy less than 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate ICD shock during 24 months of follow-up. | 2 years | — |
| Death from any cause | 2 years | Death from any cause |
| Electrical storm (3 episodes of VT in 24 hours) | 2 years | — |
Countries
Poland
Contacts
Primary ContactDerejko P Prof. Paweł Derejko, MD, PhD
Backup ContactFabijańska M Project Manager for Clinical Trials in Medicover Hospital
Outcome results
None listed