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

NCT ID: NCT05888662

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-23

Study Completion Date

2029-10-23

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Cardiomyopathy Catheter Ablation of Ventricular Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endo-epicardial ablation

Group Type EXPERIMENTAL

Endo-epicardial ablation

Intervention Type PROCEDURE

Endo-epicardial ablation of ventricular tachycardia

endocardial ablation only

Group Type ACTIVE_COMPARATOR

endocardial ablation only

Intervention Type PROCEDURE

endocardial-only catheter ablation of ventricular tachycardia

Interventions

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Endo-epicardial ablation

Endo-epicardial ablation of ventricular tachycardia

Intervention Type PROCEDURE

endocardial ablation only

endocardial-only catheter ablation of ventricular tachycardia

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raphaël MARTINS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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CHU de Bordeaux

Bordeaux, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Caen

Caen, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Centre Hospitalier Régional Universitaire de Lille

Lille, , France

Site Status NOT_YET_RECRUITING

Hospices Civils de Lyon

Lyon, , France

Site Status NOT_YET_RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

Hôpital Européen Georges Pompidou

Paris, , France

Site Status RECRUITING

Hôpital Universitaire La Pitié-Salpêtrière - Paris

Paris, , France

Site Status NOT_YET_RECRUITING

CHU de Rennes

Rennes, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Saint-Étienne

Saint-Etienne, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques

Toulouse, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau

Tours, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Raphaël MARTINS, MD, PhD

Role: CONTACT

299282517 ext. 33

Kristell COAT

Role: CONTACT

299282555 ext. 33

Facility Contacts

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Frédéric SACHER

Role: primary

Laure CHAMP RIGOT

Role: primary

Grégoire MASSOUILLIE

Role: primary

François BRIGADEAU

Role: primary

Françis BESSIERE

Role: primary

Jean-Baptiste GOURRAUD

Role: primary

Emilie VARLET

Role: primary

01 56 09 20 00 ext. +33

Xavier WAINTRAUB

Role: primary

Raphaël MARTINS

Role: primary

Karim BENALI

Role: primary

04 77 82 80 00

Jean-Philippe MAURY

Role: primary

Bertrand PIERRE

Role: primary

Other Identifiers

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35RC20_9765_EPIC-VT

Identifier Type: -

Identifier Source: org_study_id

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