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

June 23, 2025 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Not yet recruiting
        • CHU de Bordeaux
        • Contact:
          • Frédéric SACHER
      • Caen, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire De Caen
        • Contact:
          • Laure CHAMP RIGOT
      • Clermont-Ferrand, France
        • Recruiting
        • Centre Hospitalier de Clermont-Ferrand
        • Contact:
          • Grégoire MASSOUILLIE
      • Lille, France
        • Not yet recruiting
        • Centre Hospitalier Regional Universitaire de Lille
        • Contact:
          • François BRIGADEAU
      • Lyon, France
        • Not yet recruiting
        • Hospices Civils de Lyon
        • Contact:
          • Françis BESSIERE
      • Nantes, France
        • Recruiting
        • CHU de Nantes
        • Contact:
          • Jean-Baptiste GOURRAUD
      • Paris, France, 75015
        • Recruiting
        • Hopital Europeen Georges Pompidou
        • Contact:
        • Principal Investigator:
          • Emilie VARLET
      • Paris, France
        • Not yet recruiting
        • Hôpital Universitaire La Pitié-Salpêtrière - Paris
        • Contact:
          • Xavier WAINTRAUB
      • Rennes, France, 35033
        • Recruiting
        • CHU de Rennes
        • Contact:
          • Raphaël MARTINS
      • Saint-Étienne, France, 42055
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Saint-Étienne
        • Principal Investigator:
          • Karim BENALI, MD
        • Contact:
      • Toulouse, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques
        • Contact:
          • Jean-Philippe MAURY
      • Tours, France
        • Not yet recruiting
        • Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau
        • Contact:
          • Bertrand PIERRE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endo-epicardial ablation
Procedure: Endo-epicardial ablation
Endo-epicardial ablation of ventricular tachycardia
Active Comparator: endocardial ablation only
Procedure: endocardial ablation only
endocardial-only catheter ablation of ventricular tachycardia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival free from ventricular arrhythmia recurrence
Time Frame: up to 5 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of ventricular arrhythmias treated
Time Frame: up to 5 years
Number of ventricular arrhythmias treated by the defibrillator with shocks or bursts of antitachycardia pacing during follow-up or the occurrence of sustained VT/VF > 30 seconds.
up to 5 years
Percentage of patients with recurrent ventricular arrhythmia
Time Frame: up to 5 years
Percentage of patients with recurrent ventricular arrhythmia
up to 5 years
Percentage of patients with a electrical storm
Time Frame: up to 5 years
Electrical storm is defined as the occurrence of at least 3 appropriate therapies (antitachycardia pacing or shocks) delivered by the defibrillator within 24 hours.
up to 5 years
Number of serious complications
Time Frame: up to 5 years
Number of serious complications related to the procedure
up to 5 years
Number of patients hospitalized for cardiovascular reasons
Time Frame: up to 2 years
Number of patients hospitalized for cardiovascular reasons (i.e. heart failure, rhythm disorders) at 2 years
up to 2 years
Number of patients requiring a redo ablation for ventricular arrhythmia
Time Frame: Up to 5 years
Number of patients requiring a redo ablation for ventricular arrhythmia
Up to 5 years
mortality rate
Time Frame: Up to 2 years
2-year mortality rate
Up to 2 years
Number of patients in each group who are non-inducible at the end of the procedure
Time Frame: 1 day
Number of patients in each group who are non-inducible at the end of the procedure (programmed ventricular stimulation negative)
1 day
Length of hospital stay (from surgery to return home)
Time Frame: Up to 2 years
Length of hospital stay (from surgery to return home) (Day)
Up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure duration
Time Frame: 1 day
Procedure time (from puncture to catheter removal, in minutes) and duration of radiofrequency delivery (in minutes)
1 day
Percentage of patients with inappropriate therapies deliverd by the ICD
Time Frame: Up to 2 years
Percentage of patients with inappropriate therapies deliverd by the ICD at 2 years
Up to 2 years
Survival free from ventricular arrhythmia recurrence according to the treatment modality
Time Frame: Up to 5 years
Describe the risk of recurrence of ventricular arrhythmias according to the treatment modality (combined endoepicardial approach vs epicardial approach alone) and according to the location of the substrate (anterior vs non-anterior, septal vs non-septal, apical vs non-apical, lateral vs non-lateral, and inferior vs non-inferior).
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Raphaël MARTINS, MD, PhD, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2023

Primary Completion (Estimated)

October 23, 2029

Study Completion (Estimated)

October 23, 2029

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC20_9765_EPIC-VT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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