Actively Recruiting
Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT) - Multicenter, Prospective, Randomized Trial
Led by MEDICOVER SP Z O.O. · Updated on 2025-11-20
220
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
M
MEDICOVER SP Z O.O.
Lead Sponsor
N
National Institute of Cardiology, Warsaw, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two methods of catheter ablation to treat ventricular tachycardias in patients who have had a myocardial infarction and are protected by an implantable cardioverter-defibrillator (ICD). This trial focuses on post-heart attack patients with irregular heart rhythms who meet specific criteria. The study aims to evaluate the safety and effectiveness of the standard endocardial ablation versus a combined endo-epicardial approach, which may better remove arrhythmogenic tissue responsible for arrhythmias. The treatments studied are endocardial ablation, which uses radiofrequency energy applied inside the heart chambers, and endo-epicardial ablation, which adds an outer heart surface approach. In the endo-epicardial group, the pericardial sac is first inflated with carbon dioxide to safely allow puncture. Both procedures use standard catheters and electrophysiological systems common to the research centers. The study randomly assigns participants to one of these two treatment groups. Participants will be followed for up to two years to monitor outcomes including death from any cause, episodes of electrical storm (three or more ventricular tachycardia episodes within 24 hours), and appropriate ICD shocks. Assessments include clinical follow-ups and ICD monitoring to evaluate the effectiveness and safety of each ablation technique. The total participation duration includes treatment and a 24-month follow-up period to capture long-term results.
CONDITIONS
Brief Title
Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Status after myocardial infarction at least 3 months before joining the study
- Documented post-infarction ventricular tachycardia (VT) or ventricular fibrillation (VF)
- Implanted ICD at least 2 weeks before ablation or CRT-D at least 2 months before ablation
- History of one or more of the following: high energy interventions; three or more antitachycardia pacing therapies including one symptomatic; electrical storm (three or more VT episodes in 24 hours); sustained VT recorded on ECG above ICD detection threshold
- Age between 18 and 85 years
- Signed informed consent to participate in the study
You will not qualify if you...
- Obesity with body mass index over 40 kg/m2
- Left ventricle ejection fraction under 20%
- Pregnancy or breastfeeding
- Renal failure with eGFR under 20 mL/min/1.73m2
- Fresh blood clot in the left ventricle
- Suspected massive adhesions in the pericardium that may prevent safe pericardial puncture
- Previous ablation of post-infarction VT in the left ventricle
- Previous heart surgery
- Acute conditions that prevent ablation, including active infection or overt hyperthyroidism
- Active cancer
- Heart failure classified as NYHA IV
- Life expectancy less than 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-procedure recovery
Participants undergo catheter ablation for ventricular tachycardia using either an endocardial or an endo-epicardial approach. The procedure involves standard electrophysiological systems and radiofrequency ablation catheters. In the endo-epicardial group, access to the pericardial sac is preceded by CO2 insufflation to enable safe puncture.
1 ablation procedure visit and immediate post-procedure care
Duration - 24 months
Participants are monitored for efficacy and safety outcomes including recurrence of ventricular tachycardia, ICD shocks, and overall survival for up to 2 years after ablation.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 9 locations
1
Medicover Hospital
Warsaw, Masovian Voivodeship, Poland, 02-972
Actively Recruiting
2
Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Actively Recruiting
3
National Institute of Cardiology
Warsaw, Masovian Voivodeship, Poland
Not Yet Recruiting
4
University Hospital No. 1 in Bydgoszcz
Bydgoszcz, Poland
Not Yet Recruiting
5
University Clinical Center based in Gdańsk
Gdansk, Poland
Not Yet Recruiting
6
Independent Public Health Care Facility University Hospital in Krakow
Krakow, Poland
Not Yet Recruiting
7
University Clinical Hospital in Poznań
Poznan, Poland
Not Yet Recruiting
8
University Clinical Hospital No. 2 PUM in Szczecin
Szczecin, Poland
Not Yet Recruiting
9
Grochowski Hospital named after Dr. Rafał Masztak, MD
Warsaw, Poland
Not Yet Recruiting
Research Team
D
Derejko P Prof. Paweł Derejko, MD, PhD
F
Fabijańska M Project Manager for Clinical Trials in Medicover Hospital
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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