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

NCT05888662 | Recruiting

• 1 other identifier: 35RC20_9765_EPIC-VT
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 12

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.

Conditions

Ischemic Cardiomyopathy; Catheter Ablation of Ventricular Tachycardia

Keywords

ischemic cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Survival free from ventricular arrhythmia recurrence

  Survival free from ventricular arrhythmia recurrence, defined as the time interval between the date of ablation and the date of first ventricular arrhythmia recurrence. Recurrence of ventricular arrhythmia is defined as the occurrence of appropriate ICD therapy or the occurrence ventricular arrhythmia requiring hospitalisation. The occurrence of the event and the date of the event will be obtained from the ICD interrogation. Patients without recurrence will be censored at the date of last ICD interrogation

  up to 5 years

Secondary Outcomes (9)

• Number of ventricular arrhythmias treated

  up to 5 years

• Percentage of patients with recurrent ventricular arrhythmia

  up to 5 years

• Percentage of patients with a electrical storm

  up to 5 years

• Number of serious complications

  up to 5 years

• Number of patients hospitalized for cardiovascular reasons

  up to 2 years

Other Outcomes (3)

• Procedure duration

  1 day

• Percentage of patients with inappropriate therapies deliverd by the ICD

  Up to 2 years

• Survival free from ventricular arrhythmia recurrence according to the treatment modality

  Up to 5 years

Study Arms (2)

Endo-epicardial ablation

EXPERIMENTAL

Procedure: Endo-epicardial ablation

endocardial ablation only

ACTIVE COMPARATOR

Procedure: endocardial ablation only

Interventions

Endo-epicardial ablation PROCEDURE

Endo-epicardial ablation of ventricular tachycardia

Endo-epicardial ablation

endocardial ablation only PROCEDURE

endocardial-only catheter ablation of ventricular tachycardia

endocardial ablation only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age
• st 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (12)

CHU de Bordeaux

Bordeaux, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Caen

Caen, France

NOT YET RECRUITING

Centre Hospitalier de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Centre Hospitalier Régional Universitaire de Lille

Lille, France

NOT YET RECRUITING

Hospices Civils de Lyon

Lyon, France

NOT YET RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

Hôpital Européen Georges Pompidou

Paris, 75015, France

RECRUITING

Hôpital Universitaire La Pitié-Salpêtrière - Paris

Paris, France

NOT YET RECRUITING

CHU de Rennes

Rennes, 35033, France

RECRUITING

Centre Hospitalier Universitaire de Saint-Étienne

Saint-Etienne, 42055, France

NOT YET RECRUITING

Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques

Toulouse, France

NOT YET RECRUITING

Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau

Tours, France

NOT YET RECRUITING

Study Officials

• Raphaël MARTINS, MD, PhD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphaël MARTINS, MD, PhD

CONTACT

299282517; raphael.martins@chu-rennes.fr

Kristell COAT

CONTACT

299282555; kristell.coat@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 5, 2023
• Study Start: October 23, 2023
• Primary Completion (Estimated): October 23, 2029
• Study Completion (Estimated): October 23, 2029
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)