NCT07240441 Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT)
| NCT ID | NCT07240441 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MEDICOVER SP Z O.O. |
| Condition | Ventricular Tachycardias |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2030-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2025-02-03 with a primary completion date of 2030-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07240441 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Ventricular Tachycardias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07240441 currently recruiting?
Yes, NCT07240441 is actively recruiting participants. Contact the research team at pawel.derejko@medicover.pl for enrollment information.
Where is the NCT07240441 trial being conducted?
This trial is being conducted at Warsaw, Poland, Warsaw, Poland, Warsaw, Poland, Bydgoszcz, Poland and 5 additional locations.
Who is sponsoring the NCT07240441 clinical trial?
NCT07240441 is sponsored by MEDICOVER SP Z O.O.. The trial plans to enroll 220 participants.