Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT07240441

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

Led by MEDICOVER SP Z O.O. · Updated on 2025-11-20

220

Participants Needed

9

Research Sites

303 weeks

Total Duration

On this page

Sponsors

M

MEDICOVER SP Z O.O.

Lead Sponsor

N

National Institute of Cardiology, Warsaw, Poland

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Status after myocardial infarction at least 3 months before joining the study
  • Documented ventricular tachycardia or ventricular fibrillation after myocardial infarction
  • Implantable cardioverter-defibrillator (ICD) implanted at least 2 weeks before ablation, or CRT-D implanted at least 2 months before ablation
  • History of one or more of the following: high energy ICD intervention, three or more antitachycardia pacing therapies including one symptomatic, electrical storm (three or more VT episodes in 24 hours), or sustained VT recorded on ECG
  • Age between 18 and 85 years
  • Signed informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Obesity with body mass index (BMI) greater than 40 kg/m2
  • Left ventricle ejection fraction less than 20%
  • Pregnancy or breastfeeding
  • Renal failure with estimated glomerular filtration rate (eGFR) less than 20 mL/min/1.73m2
  • Fresh blood clot in the left ventricle
  • Suspected massive adhesions in the pericardium that could hinder pericardial puncture
  • Previous ablation for post-infarction ventricular tachycardia in the left ventricle
  • History of heart surgery
  • Acute conditions preventing ablation, including active infection or overt hyperthyroidism
  • Active cancer
  • Heart failure classified as NYHA class IV
  • Life expectancy less than 12 months

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 9 locations

1

Medicover Hospital

Warsaw, Masovian Voivodeship, Poland, 02-972

Actively Recruiting

2

Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Actively Recruiting

3

National Institute of Cardiology

Warsaw, Masovian Voivodeship, Poland

Not Yet Recruiting

4

University Hospital No. 1 in Bydgoszcz

Bydgoszcz, Poland

Not Yet Recruiting

5

University Clinical Center based in Gdańsk

Gdansk, Poland

Not Yet Recruiting

6

Independent Public Health Care Facility University Hospital in Krakow

Krakow, Poland

Not Yet Recruiting

7

University Clinical Hospital in Poznań

Poznan, Poland

Not Yet Recruiting

8

University Clinical Hospital No. 2 PUM in Szczecin

Szczecin, Poland

Not Yet Recruiting

9

Grochowski Hospital named after Dr. Rafał Masztak, MD

Warsaw, Poland

Not Yet Recruiting

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Research Team

D

Derejko P Prof. Paweł Derejko, MD, PhD

CONTACT

F

Fabijańska M Project Manager for Clinical Trials in Medicover Hospital

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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