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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Post-myocardial infarction VT radiofrequency ablation using a standard endocardial approach
Post-myocardial infarction VT radiofrequency ablation using an endo-epicardial approach with pericardial sac puncture preceded by CO2 insufflation
Medicover Hospital
Warsaw, Masovian Voivodeship, Poland
RECRUITINGMedical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
RECRUITINGNational Institute of Cardiology
Warsaw, Masovian Voivodeship, Poland
NOT_YET_RECRUITINGUniversity Hospital No. 1 in Bydgoszcz
Bydgoszcz, Poland
NOT_YET_RECRUITINGUniversity Clinical Center based in Gdańsk
Gdansk, Poland
NOT_YET_RECRUITINGIndependent Public Health Care Facility University Hospital in Krakow
Krakow, Poland
NOT_YET_RECRUITINGUniversity Clinical Hospital in Poznań
Poznan, Poland
NOT_YET_RECRUITINGUniversity Clinical Hospital No. 2 PUM in Szczecin
Szczecin, Poland
NOT_YET_RECRUITINGGrochowski Hospital named after Dr. Rafał Masztak, MD
Warsaw, Poland
NOT_YET_RECRUITINGDeath from any cause
Death from any cause
Time frame: 2 years
Electrical storm (3 episodes of VT in 24 hours)
Time frame: 2 years
Adequate ICD shock during 24 months of follow-up.
Time frame: 2 years
Fabijańska M Project Manager for Clinical Trials in Medicover Hospital
CONTACT
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