Endocardial VT ablation: Post-myocardial infarction VT radiofrequency ablation using a standard endocardial approach
Endo-epicardial VT ablation: Post-myocardial infarction VT radiofrequency ablation using an endo-epicardial approach with pericardial sac puncture preceded by CO2 insufflation
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Death from any cause — 2 years Death from any cause
Electrical storm (3 episodes of VT in 24 hours) — 2 years
Adequate ICD shock during 24 months of follow-up. — 2 years
Trial sites (9)
Facility
City
Region
Status
Medicover Hospital
Warsaw
Masovian Voivodeship
Recruiting
Medical University of Warsaw
Warsaw
Masovian Voivodeship
Recruiting
National Institute of Cardiology
Warsaw
Masovian Voivodeship
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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