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NCT Number: NCT07240441

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Warsaw, Warsaw, Masovian Voivodeship, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • One or more high energy interventions.
  • Three or more adequate antitachycardia pacing therapies, including one symptomatic.
  • Three or more episodes of VT in 24 hours (interrupted by ATP or shock) - electrical storm.
  • 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.

Treatment and study plan

Endocardial VT ablation

Procedure

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

Endo-epicardial VT ablation

Procedure

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

Primary outcomes

  1. Death from any cause

    Time frame: 2 years

    Death from any cause

  2. Electrical storm (3 episodes of VT in 24 hours)

    Time frame: 2 years

  3. Adequate ICD shock during 24 months of follow-up.

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Derejko P Prof. Paweł Derejko, MD, PhD

CONTACT

[email protected]

+48 603338871

Fabijańska M Project Manager for Clinical Trials in Medicover Hospital

CONTACT

[email protected]

+48 519532444

Sponsors and collaborators

Lead sponsor

MEDICOVER SP Z O.O.

Other

Collaborators

  • Medical University of Warsaw
  • National Institute of Cardiology, Warsaw, Poland

Registry information

Official study title

Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT) - Multicenter, Prospective, Randomized Trial

Acronym: EPISODE_VT

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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