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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endo-epicardial ablation | Experimental |
| |
| endocardial ablation only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endo-epicardial ablation | Procedure | Endo-epicardial ablation of ventricular tachycardia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 5 years |
| Percentage of patients with recurrent ventricular arrhythmia |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure duration | Procedure time (from puncture to catheter removal, in minutes) and duration of radiofrequency delivery (in minutes) | 1 day |
| Percentage of patients with inappropriate therapies deliverd by the ICD |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raphaël MARTINS, MD, PhD | Contact | 299282517 | 33 | raphael.martins@chu-rennes.fr |
| Kristell COAT | Contact | 299282555 | 33 | kristell.coat@chu-rennes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Raphaël MARTINS, MD, PhD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Not yet recruiting | Bordeaux | France |
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| endocardial ablation only | Procedure | endocardial-only catheter ablation of ventricular tachycardia |
|
Percentage of patients with recurrent ventricular arrhythmia |
| 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. | up to 5 years |
| Number of serious complications | Number of serious complications related to the procedure | 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 | up to 2 years |
| Number of patients requiring a redo ablation for ventricular arrhythmia | Number of patients requiring a redo ablation for ventricular arrhythmia | Up to 5 years |
| mortality rate | 2-year mortality rate | 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) | 1 day |
| Length of hospital stay (from surgery to return home) | Length of hospital stay (from surgery to return home) (Day) | Up to 2 years |
Percentage of patients with inappropriate therapies deliverd by the ICD at 2 years
| Up to 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). | Up to 5 years |
| Centre Hospitalier Universitaire de Caen | Not yet recruiting | Caen | France |
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| Centre Hospitalier de Clermont-Ferrand | Recruiting | Clermont-Ferrand | France |
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| Centre Hospitalier Régional Universitaire de Lille | Not yet recruiting | Lille | France |
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| Hospices Civils de Lyon | Not yet recruiting | Lyon | France |
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| CHU de Nantes | Recruiting | Nantes | France |
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| Hôpital Européen Georges Pompidou | Recruiting | Paris | 75015 | France |
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| Hôpital Universitaire La Pitié-Salpêtrière - Paris | Not yet recruiting | Paris | France |
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| CHU de Rennes | Recruiting | Rennes | 35033 | France |
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| Centre Hospitalier Universitaire de Saint-Étienne | Not yet recruiting | Saint-Etienne | 42055 | France |
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| Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques | Not yet recruiting | Toulouse | France |
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| Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau | Not yet recruiting | Tours | France |
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