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Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT)

RECRUITINGN/ASponsored by MEDICOVER SP Z O.O.
Actively Recruiting
PhaseN/A
SponsorMEDICOVER SP Z O.O.
Started2025-02-03
Est. completion2030-11-30
Eligibility
Age18 Years – 85 Years
Healthy vol.Accepted

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

Age: 18 Years – 85 YearsHealthy volunteers accepted
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.

Conditions5

AblationHeart DiseaseImplantable Cardiac DefibrillatorMyocardial Infarction (MI)Ventricular Tachycardias

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