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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMEDICOVER SP Z O.O.

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

One or more high energy interventions.

Disqualifiers

Obesity with BMI > 40 kg/m2.

Left ventricle ejection fraction < 20%.

Pregnancy or breastfeeding.

Renal failure (eGFR < 20 mL/min/1.73m2).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endocardial VT ablation

    Procedure/Surgery

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

  • Endo-epicardial VT ablation

    Procedure/Surgery

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

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Endocardial post MI VT ablation groupActive comparator 1 intervention
Group B: Endo-epicaridal post MI VT ablation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Death from any cause

Death from any cause

Time frame
2 years
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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MEDICOVER SP Z O.O.

Lead sponsor

National Institute of Cardiology, Warsaw, Poland

Collaborator

Medical University of Warsaw

Collaborator