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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-03

Study Completion Date

2030-11-30

Brief Summary

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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.

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Detailed Description

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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

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Ventricular Tachycardias Myocardial Infarction (MI) Implantable Cardiac Defibrillator Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endo-epicaridal post MI VT ablation group

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.

Group Type EXPERIMENTAL

Endo-epicardial VT ablation

Intervention Type PROCEDURE

Post-myocardial infarction VT radiofrequency ablation using an endo-epicardial approach with pericardial sac puncture preceded by CO2 insufflation

Endocardial post MI VT ablation group

Endocardial post MI VT radiofrequency ablation using contact force irrigated catheters, standard electrophysiological systems, electroanatomical mapping systems and RF generators.

Group Type ACTIVE_COMPARATOR

Endocardial VT ablation

Intervention Type PROCEDURE

Post-myocardial infarction VT radiofrequency ablation using a standard endocardial approach

Interventions

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Endocardial VT ablation

Post-myocardial infarction VT radiofrequency ablation using a standard endocardial approach

Intervention Type PROCEDURE

Endo-epicardial VT ablation

Post-myocardial infarction VT radiofrequency ablation using an endo-epicardial approach with pericardial sac puncture preceded by CO2 insufflation

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medicover Hospital

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING