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

Официальное название

Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients Withischemic Cardiomyopathy: a Randomized Controlled Study

Обзор

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.

Вмешательства

• Процедура Endo-epicardial ablation
  Endo-epicardial ablation of ventricular tachycardia
• Процедура endocardial ablation only
  endocardial-only catheter ablation of ventricular tachycardia

Первичные конечные точки

• Survival free from ventricular arrhythmia recurrence [Срок оценки: up to 5 years]

Вторичные конечные точки (9)

• Number of ventricular arrhythmias treated [Срок оценки: up to 5 years]
• Percentage of patients with recurrent ventricular arrhythmia [Срок оценки: up to 5 years]
• Percentage of patients with a electrical storm [Срок оценки: up to 5 years]
• Number of serious complications [Срок оценки: up to 5 years]
• Number of patients hospitalized for cardiovascular reasons [Срок оценки: up to 2 years]
• Number of patients requiring a redo ablation for ventricular arrhythmia [Срок оценки: Up to 5 years]
• mortality rate [Срок оценки: Up to 2 years]
• Number of patients in each group who are non-inducible at the end of the procedure [Срок оценки: 1 day]
• Length of hospital stay (from surgery to return home) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• 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
• Have given their free and informed consent in writing
• are affiliated to or have health insurance

Критерии исключения

• 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
• History of pericarditis
• Previous thoracic radiotherapy
• Contraindication to general anaesthesia
• Pregnant or breastfeeding woman
• History of heparin-induced thrombocytopenia type 2 (as injection is required during the procedure)
• Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 12 центров

• CHU de Bordeaux — Bordeaux
• Centre Hospitalier Universitaire de Caen — Caen
• Centre Hospitalier de Clermont-Ferrand — Clermont-Ferrand
• Centre Hospitalier Régional Universitaire de Lille — Lille
• Hospices Civils de Lyon — Lyon
• CHU de Nantes — Nantes
• Hôpital Européen Georges Pompidou — Paris
• Hôpital Universitaire La Pitié-Salpêtrière - Paris — Paris
• … и ещё 4 центра

Идентификаторы

NCT: NCT05888662 · 35RC20_9765_EPIC-VT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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