About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
One or more high energy interventions.
Disqualifiers
Obesity with BMI > 40 kg/m2.
Left ventricle ejection fraction < 20%.
Pregnancy or breastfeeding.
Renal failure (eGFR < 20 mL/min/1.73m2).
Trial design
Parallel
Treatments tested in this trial
Endocardial VT ablation
Procedure/SurgeryPost-myocardial infarction VT radiofrequency ablation using a standard endocardial approach
Endo-epicardial VT ablation
Procedure/SurgeryPost-myocardial infarction VT radiofrequency ablation using an endo-epicardial approach with pericardial sac puncture preceded by CO2 insufflation
Treatment groups
Trial outcomes
Primary outcomes
Death from any cause
Death from any cause
Electrical storm (3 episodes of VT in 24 hours)
Adequate ICD shock during 24 months of follow-up.
Sponsors and contacts
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MEDICOVER SP Z O.O.
Lead sponsor
National Institute of Cardiology, Warsaw, Poland
Collaborator
Medical University of Warsaw
Collaborator