Ventricular TachycardiasEPISODE_VTNCT07240441
Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT)
A study testing Endocardial VT ablation and Endo-epicardial VT ablation in people with Ventricular Tachycardias and Myocardial Infarction (MI), run by MEDICOVER SP Z O.O. at 9 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ventricular Tachycardias, Myocardial Infarction (MI), Implantable Cardiac Defibrillator
- What is being tested?
- Endocardial VT ablation and Endo-epicardial VT ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 9 sitesPoland
- Study dates
- 3 Feb 2025to 30 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- One or more high energy interventions.
- Three or more adequate antitachycardia pacing therapies, including one symptomatic.
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- Three or more episodes of VT in 24 hours (interrupted by ATP or shock) - electrical storm.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Fabijańska M Project Manager for Clinical Trials in Medicover Hospital contact
9 sites in 1 country
Poland9 sites, 9 recruiting
- Not yet recruiting
University Hospital No. 1 in Bydgoszcz
Bydgoszcz
Krupa W
- Not yet recruiting
University Clinical Center based in Gdańsk
Gdansk
Królak T
- Not yet recruiting
Independent Public Health Care Facility University Hospital in Krakow
Krakow
Jastrzębski M
- Not yet recruiting
University Clinical Hospital in Poznań
Poznan
- Not yet recruiting
University Clinical Hospital No. 2 PUM in Szczecin
Szczecin
Kiedrowicz R Radosław Kiedrowicz, MD, PhD, radkied@wp.pl
- Recruiting
Medicover Hospital
Warsaw, Masovian Voivodeship, 02-972
Klimowicz K Study coordinator, +48 664 985 000, karolina.klimowicz@medicover.pl
- Recruiting
Medical University of Warsaw
Warsaw, Masovian Voivodeship
Peller M Michał Peller, MD, PhD, michalpeller@gmail.com
- Not yet recruiting
National Institute of Cardiology
Warsaw, Masovian Voivodeship
Maciąg A Aleksander Maciąg, MD, PhD, amaciag@ikard.pl
- Not yet recruiting
Grochowski Hospital named after Dr. Rafał Masztak, MD
Warsaw
Baran Dr. Jakub Baran, MD, PhD, jakub.baran1111@gmail.com
About this study
Official title: Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT) - Multicenter, Prospective, Randomized 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.
Read the detailed description
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. Nowadays, most often ablation is performed using only endocardial approach. The rate of VT recurrences after such ablation may exceed 50%, which is largely due to the inability to remove all arrhythmogenic substrate. At the same time, in cases where all potentially arrhythmogenic substrate is removed, the immediate and long-term results are better, both in terms of recurrence and prognosis. Single reports on endo-epicardial ablation as the first-line therapy in patients with post-infarction VT indicate a higher efficacy of this approach compared to endocardial ablation. Similar conclusions emerge from meta-analyses. This is probably due to a more complete removal of the arrhythmogenic substrate located mainly in the epicardium or intramurally.
In the endo-epicardial group pericardial sac puncture will be performed after filling it with carbon dioxide, which creates a space for safe puncture.
Ablation procedures will be performed as standard. The electrophysiological systems and ablation electrodes used in the study will be standard devices that research centers are equipped with. Their use will be in accordance with the procedures of the center and the instructions for use.
- Conditions
- Ventricular Tachycardias, Myocardial Infarction (MI), Implantable Cardiac Defibrillator, Ablation
- Being tested
- Endocardial VT ablation, Endo-epicardial VT ablation
- Keywords
- ventricular tachycardia, myocardial infarction, epicardial access, pericardial sac puncture, ablation, implantable cardioverter defibrillator
- Medical subject headings
- Tachycardia, Ventricular, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocardial VT ablationProcedure or surgery
Post-myocardial infarction VT radiofrequency ablation using a standard endocardial approach
Endo-epicardial VT ablationProcedure or surgery
Post-myocardial infarction VT radiofrequency ablation using an endo-epicardial approach with pericardial sac puncture preceded by CO2 insufflation
| Study group | Role | What they receive |
|---|---|---|
| Endocardial post MI VT ablation group | Active comparator | Endocardial post MI VT radiofrequency ablation using contact force irrigated catheters, standard electrophysiological systems, electroanatomical mapping systems and RF generators. Receives: Procedure: Endocardial VT ablation |
| Endo-epicaridal post MI VT ablation group | Experimental | Endo-epicardial post-myocardial infarction VT radiofrequency ablation will be performed using contact force irrigated catheters, standard electrophysiological systems, electroanatomical mapping systems and RF generators. Access to the pericardial sac will be preceded by CO2 insufflation into its lumen. Receives: Procedure: Endo-epicardial VT ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from any cause
Death from any cause
Measured: 2 years
Electrical storm (3 episodes of VT in 24 hours)
Measured: 2 years
Adequate ICD shock during 24 months of follow-up.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start3 Feb 2025
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MEDICOVER SP Z O.O.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Cardiology, Warsaw, Poland, Medical University of Warsaw
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240441
- Sponsor's protocol ID
- EPISODE VT
- Other IDs
- 2024/ABM/01/00005
- Acronym
- EPISODE_VT
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT) - Multicenter, Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT07240441
- Acronym / sponsor ID
- EPISODE_VT / EPISODE VT
- Conditions
- Ventricular Tachycardias, Myocardial Infarction (MI), Implantable Cardiac Defibrillator, Ablation
- Keywords
- ventricular tachycardia, myocardial infarction, epicardial access, pericardial sac puncture, ablation, implantable cardioverter defibrillator
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- MEDICOVER SP Z O.O.University, hospital or other
- Collaborators
- National Institute of Cardiology, Warsaw, Poland, Medical University of Warsaw
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Nowadays, most often ablation is performed using only endocardial approach. The rate of VT recurrences after such ablation may exceed 50%, which is largely due to the inability to remove all arrhythmogenic substrate. At the same time, in cases where all potentially arrhythmogenic substrate is removed, the immediate and long-term results are better, both in terms of recurrence and prognosis. Single reports on endo-epicardial ablation as the first-line therapy in patients with post-infarction VT indicate a higher efficacy of this approach compared to endocardial ablation. Similar conclusions emerge from meta-analyses. This is probably due to a more complete removal of the arrhythmogenic substrate located mainly in the epicardium or intramurally.
In the endo-epicardial group pericardial sac puncture will be performed after filling it with carbon dioxide, which creates a space for safe puncture.
Ablation procedures will be performed as standard. The electrophysiological systems and ablation electrodes used in the study will be standard devices that research centers are equipped with. Their use will be in accordance with the procedures of the center and the instructions for use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocardial post MI VT ablation group | Active comparator | Procedure: Endocardial VT ablationEndocardial post MI VT radiofrequency ablation using contact force irrigated catheters, standard electrophysiological systems, electroanatomical mapping systems and RF generators. |
| Endo-epicaridal post MI VT ablation group | Experimental | Procedure: Endo-epicardial VT ablationEndo-epicardial post-myocardial infarction VT radiofrequency ablation will be performed using contact force irrigated catheters, standard electrophysiological systems, electroanatomical mapping systems and RF generators. Access to the pericardial sac will be preceded by CO2 insufflation into its lumen. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Age between 18 and 85 years.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endocardial VT ablationPost-myocardial infarction VT radiofrequency ablation using a standard endocardial approach | Procedure or surgery | Endocardial post MI VT ablation group |
| Endo-epicardial VT ablationPost-myocardial infarction VT radiofrequency ablation using an endo-epicardial approach with pericardial sac puncture preceded by CO2 insufflation | Procedure or surgery | Endo-epicaridal post MI VT ablation group |
Primary outcome
Death from any cause
Time frame: 2 years
Death from any cause
Electrical storm (3 episodes of VT in 24 hours)
Time frame: 2 years
Adequate ICD shock during 24 months of follow-up.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabijańska M Project Manager for Clinical Trials in Medicover Hospital contact
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocardial VT ablation and Endo-epicardial VT ablation in people with Ventricular Tachycardias and Myocardial Infarction (MI), run by MEDICOVER SP Z O.O. at 9 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Derejko P Prof. Paweł Derejko, MD, PhD (+48 603338871, pawel.derejko@medicover.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from any cause (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.