Clinical trial NCT05888662: Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT)
Official title: Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients Withischemic Cardiomyopathy: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Cardiomyopathy
Catheter Ablation of Ventricular Tachycardia
Keywords: ischemic cardiomyopathy
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 bypas s grafting, valve replacements, or other surgeries that may have caused pericardial adhesions)
2. Anticoagulant therapy that cannot be temporarily discontinued
3. Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy
4. History of pericarditis
5. Previous thoracic radiotherapy
6. Contraindication to general anaesthesia
7. Pregnant or breastfeeding woman
8. History of heparin-induced thrombocytopenia type 2 (as injection is required during the procedure)
9. Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent

Primary outcomes:
measure: Survival free from ventricular arrhythmia recurrence
timeFrame: up to 5 years
Secondary outcomes:
measure: Number of ventricular arrhythmias treated
timeFrame: up to 5 years
measure: Percentage of patients with recurrent ventricular arrhythmia
timeFrame: up to 5 years
measure: Percentage of patients with a electrical storm
timeFrame: up to 5 years
measure: Number of serious complications
timeFrame: up to 5 years
measure: Number of patients hospitalized for cardiovascular reasons
timeFrame: up to 2 years
measure: Number of patients requiring a redo ablation for ventricular arrhythmia
timeFrame: Up to 5 years
measure: mortality rate
timeFrame: Up to 2 years
measure: Number of patients in each group who are non-inducible at the end of the procedure
timeFrame: 1 day
Other outcomes:
measure: Procedure duration
timeFrame: 1 day
measure: Percentage of patients with inappropriate therapies deliverd by the ICD
timeFrame: Up to 2 years
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier de Clermont-Ferrand
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hôpital Universitaire La Pitié-Salpêtrière - Paris
city: Rennes
country: France
facility: CHU de Rennes
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques
city: Tours
country: France
facility: Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau
Study officials:
affiliation: Rennes University Hospital
name: Raphaël MARTINS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: