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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Endo-epicardial ablation of ventricular tachycardia
endocardial-only catheter ablation of ventricular tachycardia
CHU de Bordeaux
Bordeaux, France
NOT_YET_RECRUITINGCentre Hospitalier Universitaire de Caen
Caen, France
NOT_YET_RECRUITINGCentre Hospitalier de Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGCentre Hospitalier Régional Universitaire de Lille
Lille, France
NOT_YET_RECRUITINGHospices Civils de Lyon
Lyon, France
NOT_YET_RECRUITINGCHU de Nantes
Nantes, France
RECRUITINGHôpital Européen Georges Pompidou
Paris, France
RECRUITINGHôpital Universitaire La Pitié-Salpêtrière - Paris
Paris, France
NOT_YET_RECRUITINGCHU de Rennes
Rennes, France
RECRUITINGCentre Hospitalier Universitaire de Saint-Étienne
Saint-Etienne, France
NOT_YET_RECRUITING...and 2 more locations
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
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
Percentage of patients with recurrent ventricular arrhythmia
Percentage of patients with recurrent ventricular arrhythmia
Time frame: up to 5 years
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
Number of serious complications
Number of serious complications related to the procedure
Time frame: up to 5 years
Number of patients hospitalized for cardiovascular reasons
Number of patients hospitalized for cardiovascular reasons (i.e. heart failure, rhythm disorders) at 2 years
Time frame: up to 2 years
Number of patients requiring a redo ablation for ventricular arrhythmia
Number of patients requiring a redo ablation for ventricular arrhythmia
Time frame: Up to 5 years
mortality rate
2-year mortality rate
Time frame: Up to 2 years
Number of patients in each group who are non-inducible at the end of the procedure
Number of patients in each group who are non-inducible at the end of the procedure (programmed ventricular stimulation negative)
Time frame: 1 day
Length of hospital stay (from surgery to return home)
Length of hospital stay (from surgery to return home) (Day)
Time frame: Up to 2 years
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