Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRennes University Hospital

About this trial

Radiofrequency ablation of ventricular tachycardias (VTs) is the gold standard treatment of refractory VTs in patients with ischaemic heart disease. In this setting, ablation is usually performed endocardially. However, even after a procedural success there is a high risk of recurrence, particularly due to the inability to create transmural lesions. Indeed, only the endocardium of the LV has been ablated, while a significant part of the arrhythmia substrate may be located on the other side of the myocardial thickness, on the epicardial side of the LV.

First described in 1996, epicardial ablation, performed via a percutaneous subxyphoid approach, has since undergone considerable development. Electrophysiologists often use a double endo- and epicardial approach as first line therapy for the ablation of VTs complicating myocarditis or arrhythmogenic dysplasia of the right ventricle, where the substrate is most often epicardial.

For VT in ischaemic heart disease, electrophysiologists perform endocardial ablation, and often perform epicardial ablation only after several endocardial failures. Several observational studies suggest that a combined endo- and epicardial approach as first line therapy is associated with a reduced risk of VT recurrence. Since recurrent VT in patients with ischaemic heart disease as a prognostic impact in terms of morbidity and mortality, it appears essential to optimise rhythm management by ablation, by offering a combined approach from the as first approach to reduce the risk of recurrences.

The aim of our prospective, multicentre, controlled, randomized study is therefore to compare the rate of VT recurrence after ablation performed as first line therapy either by endocardial approach alone or by combined endo-epicardial approach.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over 18 years of age

1st radiofrequency ablation of VT complicating ischaemic heart disease

Patients with an ICD and remote monitoring

Having, for women of childbearing age, effective contraception until discharge from hospital

Disqualifiers

History of cardiac surgery compromising the epicardial approach (coronary artery bypass grafting, valve replacements, or other surgeries that may have caused pericardial adhesions)

Presence of a left intraventricular thrombus found during pre-procedure imaging

Anticoagulant therapy that cannot be temporarily discontinued

Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endo-epicardial ablation

    Procedure/Surgery

    Endo-epicardial ablation of ventricular tachycardia

  • endocardial ablation only

    Procedure/Surgery

    endocardial-only catheter ablation of ventricular tachycardia

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Endo-epicardial ablationExperimental treatment 1 intervention
Group B: endocardial ablation onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Survival free from ventricular arrhythmia recurrence

Survival free from ventricular arrhythmia recurrence, defined as the time interval between the date of ablation and the date of first ventricular arrhythmia recurrence. Recurrence of ventricular arrhythmia is defined as the occurrence of appropriate ICD therapy or the occurrence ventricular arrhythmia requiring hospitalisation. The occurrence of the event and the date of the event will be obtained from the ICD interrogation. Patients without recurrence will be censored at the date of last ICD interrogation

Time frame
up to 5 years

Secondary outcomes

1

Number of ventricular arrhythmias treated

Number of ventricular arrhythmias treated by the defibrillator with shocks or bursts of antitachycardia pacing during follow-up or the occurrence of sustained VT/VF \> 30 seconds.

Time frame
up to 5 years
2

Percentage of patients with recurrent ventricular arrhythmia

Percentage of patients with recurrent ventricular arrhythmia

Time frame
up to 5 years
3

Percentage of patients with a electrical storm

Electrical storm is defined as the occurrence of at least 3 appropriate therapies (antitachycardia pacing or shocks) delivered by the defibrillator within 24 hours.

Time frame
up to 5 years
4

Number of serious complications

Number of serious complications related to the procedure

Time frame
up to 5 years

Other outcomes

1

Procedure duration

Procedure time (from puncture to catheter removal, in minutes) and duration of radiofrequency delivery (in minutes)

Time frame
1 day
2

Percentage of patients with inappropriate therapies deliverd by the ICD

Percentage of patients with inappropriate therapies deliverd by the ICD at 2 years

Time frame
Up to 2 years
3

Survival free from ventricular arrhythmia recurrence according to the treatment modality

Describe the risk of recurrence of ventricular arrhythmias according to the treatment modality (combined endoepicardial approach vs epicardial approach alone) and according to the location of the substrate (anterior vs non-anterior, septal vs non-septal, apical vs non-apical, lateral vs non-lateral, and inferior vs non-inferior).

Time frame
Up to 5 years

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