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

NCT07240441 | Recruiting DMC

• 2 other identifiers: EPISODE VT2024/ABM/01/00005
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Ventricular Tachycardias; Myocardial Infarction (MI); Implantable Cardiac Defibrillator; Ablation

Keywords

ventricular tachycardia; myocardial infarction; epicardial access; pericardial sac puncture; ablation; implantable cardioverter defibrillator

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Procedure: Endocardial VT ablation

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.

Procedure: Endo-epicardial VT ablation

Interventions

Endocardial VT ablation PROCEDURE

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

Endocardial post MI VT ablation group

Endo-epicardial VT ablation PROCEDURE

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

Endo-epicaridal post MI VT ablation group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MEDICOVER SP Z O.O.: lead
• National Institute of Cardiology, Warsaw, Poland: collaborator
• Medical University of Warsaw: collaborator

Study Sites (9)

Medicover Hospital

Warsaw, Masovian Voivodeship, 02-972, Poland

RECRUITING

Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland

RECRUITING

National Institute of Cardiology

Warsaw, Masovian Voivodeship, Poland

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

MeSH Terms

Conditions

Tachycardia, Ventricular; Myocardial Infarction

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 20, 2025
• Study Start: February 3, 2025
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (9)