Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT)
Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT) - Multicenter, Prospective, Randomized Trial
MEDICOVER SP Z O.O.
220 participants
Feb 3, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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.
Exclusion Criteria12
- 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.
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Interventions
Post-myocardial infarction VT radiofrequency ablation using a standard endocardial approach
Post-myocardial infarction VT radiofrequency ablation using an endo-epicardial approach with pericardial sac puncture preceded by CO2 insufflation
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT07240441