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

Recruiting now · Not applicable

Conditions studied: Ventricular Tachycardias, Myocardial Infarction (MI), Implantable Cardiac Defibrillator, Ablation

In brief

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.

Key facts

Study ID

NCT07240441

Run by

MEDICOVER SP Z O.O.

People needed

220

Starts

2025-02-03

Expected to finish

2030-11-30

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.

Where it is running

• Medicover Hospital — Warsaw, Masovian Voivodeship, Poland (enrolling)
• Medical University of Warsaw — Warsaw, Masovian Voivodeship, Poland (enrolling)
• National Institute of Cardiology — Warsaw, Masovian Voivodeship, Poland
• University Hospital No. 1 in Bydgoszcz — Bydgoszcz, Poland
• University Clinical Center based in Gdańsk — Gdansk, Poland
• Independent Public Health Care Facility University Hospital in Krakow — Krakow, Poland
• University Clinical Hospital in Poznań — Poznan, Poland
• University Clinical Hospital No. 2 PUM in Szczecin — Szczecin, Poland
• Grochowski Hospital named after Dr. Rafał Masztak, MD — Warsaw, Poland

Full record on ClinicalTrials.gov

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