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Compares treatment options for Ventricular Tachycardias
Official title Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT)
ClinicalTrials.gov ID: NCT07240441
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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:
- One or more high energy interventions.
- Three or more adequate antitachycardia pacing therapies, including one symptomatic.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Masovian Voivodeship, Poland
- Bydgoszcz, Poland
- Gdansk, Poland
- Krakow, Poland
- Poznan, Poland
- Szczecin, Poland
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Masovian Voivodeship, Poland; Bydgoszcz, Poland; Gdansk, Poland; Krakow, Poland; Poznan, Poland; Szczecin, Poland and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.