Actively Recruiting
Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy: a Randomized Controlled Study
Led by Rennes University Hospital · Updated on 2025-06-27
150
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two approaches for treating ventricular tachycardia (VT) in patients with ischemic heart disease. VT is a serious heart rhythm problem, and while current standard treatment uses radiofrequency ablation on the inner heart surface (endocardial), there is a risk of VT returning because the outer heart surface (epicardial) might also be involved. The study evaluates whether combining both endocardial and epicardial ablation as a first treatment reduces VT recurrence compared to endocardial ablation alone. Participants will be randomly assigned to receive either the combined endo-epicardial ablation or endocardial-only ablation. Both procedures involve catheter-based radiofrequency energy to target heart tissue causing VT. The combined approach uses a percutaneous subxyphoid method to access the epicardial surface. The study is conducted across several centers and includes a long-term follow-up of up to five years to monitor outcomes. Throughout the study, participants will be monitored for ventricular arrhythmia recurrence and other heart-related events. Assessments include hospitalizations, need for repeat ablations, electrical storm occurrences, and serious complications. The main outcome is survival free from VT recurrence over five years. Data on hospital stay length and mortality up to two years will also be collected. Participants must have implanted defibrillators with remote monitoring and will be followed regularly to evaluate the treatment effects and safety.
CONDITIONS
Brief Title
Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- First radiofrequency ablation of ventricular tachycardia related to ischemic heart disease
- Presence of an implantable cardioverter defibrillator (ICD) with remote monitoring
- Women of childbearing age must use effective contraception until hospital discharge
- Provided free and informed written consent
- Affiliated with or covered by health insurance
You will not qualify if you...
- History of cardiac surgery that may affect the epicardial approach, such as coronary artery bypass grafting or valve replacements
- Presence of a left intraventricular thrombus detected by pre-procedure imaging
- Cannot temporarily stop anticoagulant therapy
- Unable to switch from double antiplatelet therapy to single antiplatelet therapy temporarily
- History of pericarditis
- Previous thoracic radiotherapy
- Contraindication to general anesthesia
- Pregnant or breastfeeding women
- History of heparin-induced thrombocytopenia type 2
- Persons under legal protection, deprived of liberty, or unable to give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo catheter ablation of ventricular tachycardia either with an endo-epicardial approach or endocardial-only approach.
1 procedure visit and hospitalization until discharge
Duration - Up to 5 years
Participants are monitored for up to 5 years to assess survival free from ventricular arrhythmia recurrence and other cardiovascular outcomes.
Regular follow-up visits depending on clinical status
Trial Site Locations
Total: 12 locations
1
CHU de Bordeaux
Bordeaux, France
Not Yet Recruiting
2
Centre Hospitalier Universitaire de Caen
Caen, France
Not Yet Recruiting
3
Centre Hospitalier de Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
4
Centre Hospitalier Régional Universitaire de Lille
Lille, France
Not Yet Recruiting
5
Hospices Civils de Lyon
Lyon, France
Not Yet Recruiting
6
CHU de Nantes
Nantes, France
Actively Recruiting
7
Hôpital Européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
8
Hôpital Universitaire La Pitié-Salpêtrière - Paris
Paris, France
Not Yet Recruiting
9
CHU de Rennes
Rennes, France, 35033
Actively Recruiting
10
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Etienne, France, 42055
Not Yet Recruiting
11
Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques
Toulouse, France
Not Yet Recruiting
12
Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau
Tours, France
Not Yet Recruiting
Research Team
R
Raphaël MARTINS, MD, PhD
K
Kristell COAT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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