Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05888662

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

Led by Rennes University Hospital · Updated on 2025-06-27

150

Participants Needed

12

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years of age
  • Undergoing first radiofrequency ablation of ventricular tachycardia related to ischemic heart disease
  • Have an implantable cardioverter defibrillator (ICD) with remote monitoring
  • Women of childbearing age must use effective contraception until hospital discharge
  • Provided free and informed written consent
  • Affiliated with or have health insurance
Not Eligible

You will not qualify if you...

  • History of cardiac surgery that could compromise epicardial approach (e.g., coronary artery bypass grafting, valve replacements)
  • Presence of left intraventricular thrombus on pre-procedure imaging
  • Anticoagulant therapy that cannot be temporarily stopped
  • Double antiplatelet therapy that cannot be replaced by single antiplatelet therapy
  • History of pericarditis
  • Previous thoracic radiotherapy
  • Contraindication to general anesthesia
  • Pregnant or breastfeeding women
  • History of heparin-induced thrombocytopenia type 2
  • Persons under legal protection, deprived of liberty, or unable to give consent

AI-Screening

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Trial Site Locations

Total: 12 locations

1

CHU de Bordeaux

Bordeaux, France

Not Yet Recruiting

2

Centre Hospitalier Universitaire de Caen

Caen, France

Not Yet Recruiting

3

Centre Hospitalier de Clermont-Ferrand

Clermont-Ferrand, France

Actively Recruiting

4

Centre Hospitalier Régional Universitaire de Lille

Lille, France

Not Yet Recruiting

5

Hospices Civils de Lyon

Lyon, France

Not Yet Recruiting

6

CHU de Nantes

Nantes, France

Actively Recruiting

7

Hôpital Européen Georges Pompidou

Paris, France, 75015

Actively Recruiting

8

Hôpital Universitaire La Pitié-Salpêtrière - Paris

Paris, France

Not Yet Recruiting

9

CHU de Rennes

Rennes, France, 35033

Actively Recruiting

10

Centre Hospitalier Universitaire de Saint-Étienne

Saint-Etienne, France, 42055

Not Yet Recruiting

11

Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques

Toulouse, France

Not Yet Recruiting

12

Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau

Tours, France

Not Yet Recruiting

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Research Team

R

Raphaël MARTINS, MD, PhD

CONTACT

K

Kristell COAT

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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