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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Bordeaux
NOT_YET_RECRUITING
Bordeaux
Centre Hospitalier Universitaire de Caen
NOT_YET_RECRUITING
Caen
Centre Hospitalier de Clermont-Ferrand
RECRUITING
Clermont-ferrand
Centre Hospitalier Régional Universitaire de Lille
NOT_YET_RECRUITING
Lille
Hospices Civils de Lyon
NOT_YET_RECRUITING
Lyon
CHU de Nantes
RECRUITING
Nantes
Hôpital Européen Georges Pompidou
RECRUITING
Paris
Hôpital Universitaire La Pitié-Salpêtrière - Paris
NOT_YET_RECRUITING
Paris
CHU de Rennes
RECRUITING
Rennes
Centre Hospitalier Universitaire de Saint-Étienne
NOT_YET_RECRUITING
Saint-etienne
Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques
NOT_YET_RECRUITING
Toulouse
Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Raphaël MARTINS, MD, PhD
raphael.martins@chu-rennes.fr
299282517
Backup
Kristell COAT
kristell.coat@chu-rennes.fr
299282555
Time Frame
Start Date: 2023-10-23
Estimated Completion Date: 2029-10-23
Participants
Target number of participants: 150
Treatments
Experimental: Endo-epicardial ablation
Active_comparator: endocardial ablation only
Sponsors
Leads: Rennes University Hospital

This content was sourced from clinicaltrials.gov

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