Skip to main content
Clinical Trials/NCT05888662
NCT05888662
Recruiting
Not Applicable

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

Rennes University Hospital12 sites in 1 country150 target enrollmentOctober 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Cardiomyopathy
Sponsor
Rennes University Hospital
Enrollment
150
Locations
12
Primary Endpoint
Survival free from ventricular arrhythmia recurrence
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 23, 2023
End Date
October 23, 2029
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Rennes University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients over 18 years of age
  • 1st 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)
  • Number of patients requiring a redo ablation for ventricular arrhythmia(Up to 5 years)
  • mortality rate(Up to 2 years)
  • Number of patients in each group who are non-inducible at the end of the procedure(1 day)
  • Length of hospital stay (from surgery to return home)(Up to 2 years)

Study Sites (12)

Loading locations...

Similar Trials