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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Endo-epicardial ablation
Procedure/SurgeryEndo-epicardial ablation of ventricular tachycardia
endocardial ablation only
Procedure/Surgeryendocardial-only catheter ablation of ventricular tachycardia
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
Percentage of patients with recurrent ventricular arrhythmia
Percentage of patients with recurrent ventricular arrhythmia
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.
Number of serious complications
Number of serious complications related to the procedure
Other outcomes
Procedure duration
Procedure time (from puncture to catheter removal, in minutes) and duration of radiofrequency delivery (in minutes)
Percentage of patients with inappropriate therapies deliverd by the ICD
Percentage of patients with inappropriate therapies deliverd by the ICD at 2 years
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).
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