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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients over 18 years of age 2. 1st radiofrequency ablation of VT complicating ischaemic heart disease 3. Patients with an ICD and remote monitoring 4. Having, for women of childbearing age, effective contraception until discharge from hospital 5. Have given their free and willing to sign a consent form in writing 6. are affiliated to or have health insurance Who Should NOT Join This Trial: 1. History of cardiac surgery compromising the epicardial approach (coronary artery bypass grafting, valve replacements, or other surgeries that may have caused pericardial adhesions) 2. Presence of a left intraventricular thrombus found during pre-procedure imaging 3. Anticoagulant therapy that cannot be temporarily discontinued 4. Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy 5. History of pericarditis 6. Previous thoracic radiotherapy 7. Contraindication to general anaesthesia 8. Pregnant or breastfeeding woman 9. History of heparin-induced thrombocytopenia type 2 (as injection is required during the procedure) 10. Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patients over 18 years of age 2. 1st radiofrequency ablation of VT complicating ischaemic heart disease 3. Patients with an ICD and remote monitoring 4. Having, for women of childbearing age, effective contraception until discharge from hospital 5. Have given their free and informed consent in writing 6. are affiliated to or have health insurance Exclusion Criteria: 1. History of cardiac surgery compromising the epicardial approach (coronary artery bypass grafting, valve replacements, or other surgeries that may have caused pericardial adhesions) 2. Presence of a left intraventricular thrombus found during pre-procedure imaging 3. Anticoagulant therapy that cannot be temporarily discontinued 4. Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy 5. History of pericarditis 6. Previous thoracic radiotherapy 7. Contraindication to general anaesthesia 8. Pregnant or breastfeeding woman 9. History of heparin-induced thrombocytopenia type 2 (as injection is required during the procedure) 10. Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent

Treatments Being Tested

PROCEDURE

Endo-epicardial ablation

Endo-epicardial ablation of ventricular tachycardia

PROCEDURE

endocardial ablation only

endocardial-only catheter ablation of ventricular tachycardia

Locations (12)

CHU de Bordeaux
Bordeaux, France
Centre Hospitalier Universitaire de Caen
Caen, France
Centre Hospitalier de Clermont-Ferrand
Clermont-Ferrand, France
Centre Hospitalier Régional Universitaire de Lille
Lille, France
Hospices Civils de Lyon
Lyon, France
CHU de Nantes
Nantes, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital Universitaire La Pitié-Salpêtrière - Paris
Paris, France
CHU de Rennes
Rennes, France
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Etienne, France
Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques
Toulouse, France
Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau
Tours, France