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

Last updated: October 26, 2023
Sponsor: Rennes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Attack (Myocardial Infarction)

Congestive Heart Failure

Fast Heart Rate (Tachycardia)

Treatment

Endo-epicardial ablation

endocardial ablation only

Clinical Study ID

NCT05888662
35RC20_9765_EPIC-VT
  • Ages > 18
  • All Genders

Study 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

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 fromhospital
  5. Have given their free and informed consent in writing
  6. are affiliated to or have health insurance

Exclusion

Exclusion Criteria:

  1. History of cardiac surgery compromising the epicardial approach (coronary artery bypass grafting, valve replacements, or other surgeries that may have caused pericardialadhesions)
  2. Anticoagulant therapy that cannot be temporarily discontinued
  3. Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelettherapy
  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 duringthe procedure)
  9. Person under legal protection (safeguard of justice, curatorship, guardianship),deprived of liberty, or unable to express consent

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Endo-epicardial ablation
Phase:
Study Start date:
October 23, 2023
Estimated Completion Date:
October 23, 2028

Connect with a study center

  • CHU de Bordeaux

    Bordeaux,
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Caen

    Caen,
    France

    Site Not Available

  • Centre Hospitalier de Clermont-Ferrand

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Centre Hospitalier Régional Universitaire de Lille

    Lille,
    France

    Site Not Available

  • Hospices Civils de Lyon

    Lyon,
    France

    Site Not Available

  • CHU de Nantes

    Nantes,
    France

    Active - Recruiting

  • Hôpital Universitaire La Pitié-Salpêtrière - Paris

    Paris,
    France

    Site Not Available

  • CHU de Rennes

    Rennes, 35033
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques

    Toulouse,
    France

    Site Not Available

  • Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau

    Tours,
    France

    Site Not Available

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