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
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
Treatments tested in this trial
- Endo-epicardial ablation
- endocardial ablation only