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

Ischemic Cardiomyopathy Clinical Trial

— EPIC-VT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888662
• Other study ID #: 35RC20_9765_EPIC-VT
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2023
• Est. completion date: October 23, 2028

Study information

• Verified date: October 2023
• Source: Rennes University Hospital
• Contact: Raphaël MARTINS, MD, PhD
• Phone: 299282517
• Email: raphael.martins[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 23, 2028
• Est. primary completion date: October 23, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 bypas s grafting, valve replacements, or other surgeries that may have caused pericardial adhesions)

2. Anticoagulant therapy that cannot be temporarily discontinued

3. Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy

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 during the procedure)

9. Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemia
• Ischemic Cardiomyopathy
• Tachycardia
• Tachycardia, Ventricular

Intervention

Procedure:
• Endo-epicardial ablation
Endo-epicardial ablation of ventricular tachycardia
• endocardial ablation only
endocardial-only catheter ablation of ventricular tachycardia

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	Centre Hospitalier Universitaire de Caen	Caen
France	Centre Hospitalier de Clermont-Ferrand	Clermont-Ferrand
France	Centre Hospitalier Régional Universitaire de Lille	Lille
France	Hospices Civils de Lyon	Lyon
France	CHU de Nantes	Nantes
France	Hôpital Universitaire La Pitié-Salpêtrière - Paris	Paris
France	CHU de Rennes	Rennes
France	Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques	Toulouse
France	Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedure duration	Procedure time (from puncture to catheter removal, in minutes) and duration of radiofrequency delivery (in minutes)	1 day
Other	Percentage of patients with inappropriate therapies deliverd by the ICD	Percentage of patients with inappropriate therapies deliverd by the ICD at 2 years	Up to 2 years
Primary	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 of sustained VT/VF > 30 seconds 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	Number of ventricular arrhythmias treated	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
Secondary	Percentage of patients with recurrent ventricular arrhythmia	Percentage of patients with recurrent ventricular arrhythmia	up to 5 years
Secondary	Percentage of patients with a electrical storm	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
Secondary	Number of serious complications	Number of serious complications related to the procedure	up to 5 years
Secondary	Number of patients hospitalized for cardiovascular reasons	Number of patients hospitalized for cardiovascular reasons (i.e. heart failure, rhythm disorders) at 2 years	up to 2 years
Secondary	Number of patients requiring a redo ablation for ventricular arrhythmia	Number of patients requiring a redo ablation for ventricular arrhythmia	Up to 5 years
Secondary	mortality rate	2-year mortality rate	Up to 2 years
Secondary	Number of patients in each group who are non-inducible at the end of the procedure	Number of patients in each group who are non-inducible at the end of the procedure (programmed ventricular stimulation negative)	1 day