Endo-epicardial versus endocardial catheter ablation for post-heart attack ventricular tachycardia

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

This study will see if adding an epicardial approach (through the pericardial sac) to standard endocardial catheter ablation reduces recurrent ventricular tachycardia in people who have had a heart attack and have an ICD.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Medicover Sp Z O.o. (Academic / other)
• Locations: 9 sites (Warsaw, Masovian Voivodeship and 8 other locations)
• Trial ID: NCT07240441 on ClinicalTrials.gov

What this trial studies

The trial compares two interventional approaches for post-myocardial infarction ventricular tachycardia: standard endocardial-only ablation versus a combined endo-epicardial ablation that accesses the pericardial space. In the endo-epicardial group a pericardial puncture is performed after filling the space with carbon dioxide to create a safer working area. Procedures use standard electrophysiology systems and ablation catheters available at participating centers. Patients protected by an implantable cardioverter-defibrillator will be treated and followed for procedural safety and rates of VT recurrence.

Who should consider this trial

Good fit: People aged 18–85 with prior myocardial infarction (≥3 months), documented post-infarction VT/VF, and an implanted ICD or CRT-D who meet the study's episode/therapy history criteria are ideal candidates.

Not a fit: Patients with very low ejection fraction (<20%), severe obesity (BMI >40), advanced renal failure (eGFR <20), pregnancy, fresh left ventricular thrombus, or suspected massive pericardial adhesions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combined endo-epicardial approach could lower VT recurrence and improve long-term outcomes after a heart attack.

How similar studies have performed: Single reports and meta-analyses have suggested higher efficacy for first-line endo-epicardial ablation in post-infarction VT compared with endocardial-only approaches.

Eligibility criteria

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.

Where this trial is running

Warsaw, Masovian Voivodeship and 8 other locations

• Medicover Hospital — Warsaw, Masovian Voivodeship, 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)

Study contacts

• Study coordinator: Derejko P Prof. Paweł Derejko, MD, PhD

Conditions Ventricular Tachycardias; Myocardial Infarction; Implantable Cardiac Defibrillator; Ablation; ventricular tachycardia; myocardial infarction; epicardial access; pericardial sac puncture