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Clinical Trials in Poland / NCT07240441
Recruiting Not applicable

Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT)

NCT07240441 · tracked via the Priya Life Science Poland tracker
Sponsor
MEDICOVER SP Z O.O
Phase
Not applicable
Started
2025-02-03
Last updated
2025-11-20

Condition(s) studied

Ventricular TachycardiasMyocardial Infarction (MI)Implantable Cardiac DefibrillatorAblation

Investigational drug(s) / intervention(s)

Endocardial VT ablationEndo-epicardial VT ablation

Endocardial VT ablation: Post-myocardial infarction VT radiofrequency ablation using a standard endocardial approach

Endo-epicardial VT ablation: Post-myocardial infarction VT radiofrequency ablation using an endo-epicardial approach with pericardial sac puncture preceded by CO2 insufflation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Medicover Hospital Warsaw Masovian Voivodeship Recruiting
Medical University of Warsaw Warsaw Masovian Voivodeship Recruiting
National Institute of Cardiology Warsaw Masovian Voivodeship Not Yet Recruiting
University Hospital No. 1 in Bydgoszcz Bydgoszcz Poland Not Yet Recruiting
University Clinical Center based in Gdańsk Gdansk Poland Not Yet Recruiting
Independent Public Health Care Facility University Hospital in Krakow Krakow Poland Not Yet Recruiting
University Clinical Hospital in Poznań Poznan Poland Not Yet Recruiting
University Clinical Hospital No. 2 PUM in Szczecin Szczecin Poland Not Yet Recruiting
Grochowski Hospital named after Dr. Rafał Masztak, MD Warsaw Poland Not Yet Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07240441 on ClinicalTrials.gov ↗ ← All trials in Poland