Ischemic CardiomyopathyEPIC-VTNCT05888662
Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT)
A study testing Endo-epicardial ablation and endocardial ablation only in people with Ischemic Cardiomyopathy and Catheter Ablation of Ventricular Tachycardia, run by Rennes University Hospital at 12 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Cardiomyopathy, Catheter Ablation of Ventricular Tachycardia
- What is being tested?
- Endo-epicardial ablation and endocardial ablation only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 12 sitesFrance
- Study dates
- 23 Oct 2023to 23 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 12 recruiting
- Not yet recruiting
CHU de Bordeaux
Bordeaux
Frédéric SACHER
- Not yet recruiting
Centre Hospitalier Universitaire de Caen
Caen
Laure CHAMP RIGOT
- Recruiting
Centre Hospitalier de Clermont-Ferrand
Clermont-Ferrand
Grégoire MASSOUILLIE
- Not yet recruiting
Centre Hospitalier Régional Universitaire de Lille
Lille
François BRIGADEAU
- Not yet recruiting
Hospices Civils de Lyon
Lyon
Françis BESSIERE
- Recruiting
CHU de Nantes
Nantes
Jean-Baptiste GOURRAUD
- Recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
Emilie VARLET, 01 56 09 20 00 ext. +33, emilie.varlet@aphp.fr
Emilie VARLET
- Not yet recruiting
Hôpital Universitaire La Pitié-Salpêtrière - Paris
Paris
Xavier WAINTRAUB
- Recruiting
CHU de Rennes
Rennes, 35033
Raphaël MARTINS
- Not yet recruiting
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Etienne, 42055
Karim BENALI, 04 77 82 80 00, Karim.Benali@chu-st-etienne.fr
Karim BENALI, MD
- Not yet recruiting
Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques
Toulouse
Jean-Philippe MAURY
- Not yet recruiting
Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau
Tours
Bertrand PIERRE
About this study
Official title: Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients Withischemic Cardiomyopathy: a Randomized Controlled Study
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.
Read more
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.
- Being tested
- Endo-epicardial ablation, endocardial ablation only
- Keywords
- ischemic cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo-epicardial ablationProcedure or surgery
Endo-epicardial ablation of ventricular tachycardia
endocardial ablation onlyProcedure or surgery
endocardial-only catheter ablation of ventricular tachycardia
| Study group | Role | What they receive |
|---|---|---|
| Endo-epicardial ablation | Experimental | Not described Receives: Procedure: Endo-epicardial ablation |
| endocardial ablation only | Active comparator | Not described Receives: Procedure: endocardial ablation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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
Measured: up to 5 years
Secondary outcomes (9)
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.
Measured: up to 5 years
Percentage of patients with recurrent ventricular arrhythmia
Percentage of patients with recurrent ventricular arrhythmia
Measured: up to 5 years
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.
Measured: up to 5 years
Number of serious complications
Number of serious complications related to the procedure
Measured: up to 5 years
Number of patients hospitalized for cardiovascular reasons
Number of patients hospitalized for cardiovascular reasons (i.e. heart failure, rhythm disorders) at 2 years
Measured: up to 2 years
Number of patients requiring a redo ablation for ventricular arrhythmia
Number of patients requiring a redo ablation for ventricular arrhythmia
Measured: Up to 5 years
mortality rate
2-year mortality rate
Measured: Up to 2 years
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)
Measured: 1 day
Length of hospital stay (from surgery to return home)
Length of hospital stay (from surgery to return home) (Day)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start23 Oct 2023
- Primary completion23 Oct 2029 (estimated)
- Study completion23 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphaël MARTINS, MD, PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888662
- Sponsor's protocol ID
- 35RC20_9765_EPIC-VT
- Acronym
- EPIC-VT
- Status last verified
- Jun 2025
- First submitted
- 15 May 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients Withischemic Cardiomyopathy: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05888662
- Acronym / sponsor ID
- EPIC-VT / 35RC20_9765_EPIC-VT
- Keywords
- ischemic cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 23 Oct 2029 (estimated)
- Study completion
- 23 Oct 2029 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endo-epicardial ablation | Experimental | Procedure: Endo-epicardial ablation |
| endocardial ablation only | Active comparator | Procedure: endocardial ablation only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endo-epicardial ablationEndo-epicardial ablation of ventricular tachycardia | Procedure or surgery | Endo-epicardial ablation |
| endocardial ablation onlyendocardial-only catheter ablation of ventricular tachycardia | Procedure or surgery | endocardial ablation only |
Primary outcome
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
9 secondary outcomes
Number of ventricular arrhythmias treated
Time frame: up to 5 years
Percentage of patients with recurrent ventricular arrhythmia
Time frame: up to 5 years
Percentage of patients with a electrical storm
Time frame: up to 5 years
Number of serious complications
Time frame: up to 5 years
Number of patients hospitalized for cardiovascular reasons
Time frame: up to 2 years
Number of patients requiring a redo ablation for ventricular arrhythmia
Time frame: Up to 5 years
mortality rate
Time frame: Up to 2 years
Number of patients in each group who are non-inducible at the end of the procedure
Time frame: 1 day
Length of hospital stay (from surgery to return home)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raphaël MARTINS, MD, PhD principal investigator
Rennes University Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endo-epicardial ablation and endocardial ablation only in people with Ischemic Cardiomyopathy and Catheter Ablation of Ventricular Tachycardia, run by Rennes University Hospital at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphaël MARTINS, MD, PhD (299282517 ext. 33, raphael.martins@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival free from ventricular arrhythmia recurrence (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.