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

November 18, 2025 updated by: MEDICOVER SP Z O.O.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
      • Bydgoszcz, Poland
        • Not yet recruiting
        • University Hospital No. 1 in Bydgoszcz
        • Contact:
          • Krupa W
      • Gdansk, Poland
        • Not yet recruiting
        • University Clinical Center based in Gdańsk
        • Contact:
          • Królak T
      • Krakow, Poland
        • Not yet recruiting
        • Independent Public Health Care Facility University Hospital in Krakow
        • Contact:
          • Jastrzębski M
      • Poznan, Poland
        • Not yet recruiting
        • University Clinical Hospital in Poznań
      • Szczecin, Poland
        • Not yet recruiting
        • University Clinical Hospital No. 2 PUM in Szczecin
        • Contact:
          • Kiedrowicz R Radosław Kiedrowicz, MD, PhD
          • Email: radkied@wp.pl
      • Warsaw, Poland
        • Not yet recruiting
        • Grochowski Hospital named after Dr. Rafał Masztak, MD
        • Contact:
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-972
      • Warsaw, Masovian Voivodeship, Poland
        • Recruiting
        • Medical University of Warsaw
        • Contact:
      • Warsaw, Masovian Voivodeship, Poland
        • Not yet recruiting
        • National Institute of Cardiology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Endocardial post MI VT ablation group
Endocardial post MI VT radiofrequency ablation using contact force irrigated catheters, standard electrophysiological systems, electroanatomical mapping systems and RF generators.
Procedure: Endocardial VT ablation
Post-myocardial infarction VT radiofrequency ablation using a standard endocardial approach
Experimental: Endo-epicaridal post MI VT ablation group
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.
Procedure: Endo-epicardial VT ablation
Post-myocardial infarction VT radiofrequency ablation using an endo-epicardial approach with pericardial sac puncture preceded by CO2 insufflation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Death from any cause
Time Frame: 2 years
Death from any cause
2 years
Electrical storm (3 episodes of VT in 24 hours)
Time Frame: 2 years
2 years
Adequate ICD shock during 24 months of follow-up.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MEDICOVER SP Z O.O.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of Warsaw
National Institute of Cardiology, Warsaw, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPISODE VT
  • 2024/ABM/01/00005 (Other Grant/Funding Number: MEDICAL RESEARCH AGENCY (AGENCJA BADAŃ MEDYCZNYCH - PL))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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