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| ID | Type | Description | Link |
|---|---|---|---|
| 2024/ABM/01/00005 | Other Grant/Funding Number | MEDICAL RESEARCH AGENCY (AGENCJA BADAŃ MEDYCZNYCH - PL) |
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| Name | Class |
|---|---|
| National Institute of Cardiology, Warsaw, Poland | OTHER |
| Medical University of Warsaw | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endocardial post MI VT ablation group | Active Comparator | Endocardial post MI VT radiofrequency ablation using contact force irrigated catheters, standard electrophysiological systems, electroanatomical mapping systems and RF generators. |
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| Endo-epicaridal post MI VT ablation group | Experimental | Endo-epicardial post-myocardial infarction VT radiofrequency ablation will be performed using contact force irrigated catheters, standard electrophysiological systems, electroanatomical mapping systems and RF generators. Access to the pericardial sac will be preceded by CO2 insufflation into its lumen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocardial VT ablation | Procedure | Post-myocardial infarction VT radiofrequency ablation using a standard endocardial approach |
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| Measure | Description | Time Frame |
|---|---|---|
| Death from any cause | Death from any cause | 2 years |
| Electrical storm (3 episodes of VT in 24 hours) | 2 years | |
| Adequate ICD shock during 24 months of follow-up. | 2 years |
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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:
Age between 18 and 85 years.
Signed informed consent to participate in the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Derejko P Prof. Paweł Derejko, MD, PhD | Contact | +48 603338871 | pawel.derejko@medicover.pl | |
| Fabijańska M Project Manager for Clinical Trials in Medicover Hospital | Contact | +48 519532444 | magdalena.fabijanska@medicover.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicover Hospital | Recruiting | Warsaw | Masovian Voivodeship | 02-972 | Poland |
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| Endo-epicardial VT ablation | Procedure | Post-myocardial infarction VT radiofrequency ablation using an endo-epicardial approach with pericardial sac puncture preceded by CO2 insufflation |
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| Medical University of Warsaw | Recruiting | Warsaw | Masovian Voivodeship | Poland |
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| National Institute of Cardiology | Not yet recruiting | Warsaw | Masovian Voivodeship | Poland |
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| University Hospital No. 1 in Bydgoszcz | Not yet recruiting | Bydgoszcz | Poland |
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| University Clinical Center based in Gdańsk | Not yet recruiting | Gdansk | Poland |
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| Independent Public Health Care Facility University Hospital in Krakow | Not yet recruiting | Krakow | Poland |
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| University Clinical Hospital in Poznań | Not yet recruiting | Poznan | Poland |
| University Clinical Hospital No. 2 PUM in Szczecin | Not yet recruiting | Szczecin | Poland |
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| Grochowski Hospital named after Dr. Rafał Masztak, MD | Not yet recruiting | Warsaw | Poland |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
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