Ventricular ArrhythmiaEP-SCOPENCT07020702
ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction
A study testing Implantation of an ICD in people with Ventricular Arrhythmia and Cardiomyopathies, run by University Hospital, Bordeaux at 3 sites in France.
Trial summary
EP-SCOPE is a prospective, multicentric, non-randomized pilot study that aims to estimate the risk of life-threatening ventricular arrhythmia through use of advanced electrophysiological studies in patients with ischemic or non-ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) <50% and risk… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Arrhythmia, Cardiomyopathies, Left Ventricular Ejection Fraction Less Then or Equal to 50percent
- What is being tested?
- Implantation of an ICD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 3 sitesFrance
- Study dates
- 12 Jun 2023to 12 Sep 2030
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with cardiomyopathy with 35%<LVEF<50% and at least one risk factor
- Patients with cardiomyopathy with LVEF≤35% and an indication for cardiac resynchronisation
Who cannot join
- Patients who are minors or aged 80 or over
- Patients with unstable coronary artery disease
- Myocardial infarction less than 40 days old
- Coronary revascularisation <90 days
- Patients with intracardiac thrombus
- Patients with a mechanical heart valve
Show all 10Show fewer
- Patient implanted with an automatic defibrillator
- Patient life expectancy <1 year
- Pregnant or breast-feeding women
- Anti-arrhythmic drugs other than beta-blockers and amiodarone
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Grégoire MASSOULLIE, MD, +33(0)4 73 75 14 10, gmassoullie@chuclermontferrand.fr
Grégoire MASSOULLIE
- Recruiting
CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévêque
Pessac, 33604
Mélissa LABEQUE, +33(0)5 57 62 31 32, melissa.lavevre@chu-bordeaux.fr
Sylvain PLOUX
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42270
Karim BENALI, MD, +33(0)4 77 82 83 40, karim.benali@chu-stetienne.fr
Karim BENALI, MD
About this study
EP-SCOPE is a prospective, multicentric, non-randomized pilot study that aims to estimate the risk of life-threatening ventricular arrhythmia through use of advanced electrophysiological studies in patients with ischemic or non-ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) <50% and risk factors of ventricular arrhythmia, otherwise not considered for implantation of an implantable cardioverter defibrillator (ICD).
The objective is to assess the effectiveness of a risk stratification strategy based on detailed electrophysiological exploration of the left ventricle and programmed ventricular stimulation.
Read the detailed description
Responsible for 10% of deaths in the general population, sudden cardiac death is mostly caused by malignant ventricular arrhythmias (80%). These arrhythmias mainly occur in cardiomyopathies (75-90%). Currently, the prevention of sudden death is based on risk stratification according to the evaluation of myocardial contractility with indications for prophylactic ICD implantation reserved for LVEF ≤ 35%. This predictor is notoriously insufficient for several main reasons: 1) While ICDs are indicated in patients with LVEF ≤35%, only a minority (2 -5% per year) will suffer from arrhythmia and therefore benefits from ICD implantation, while all will be subject to potential complications. 2) The majority of sudden death (70-80%) occur in patients with LVEF >35%; while they have a lower arrhythmia risk (1-2% per year), they constitute a population four times larger, which is not stratified. 3) Finally, the cardiomyopathy population is broad, and include distinct clinical scenarios that are not specifically addressed.
While conventional electrophysiological studies only boast a limited number of measurements, the proposed strategy is a detailed electrophysiological characterization of the altered ventricle. Measurements include a detailed mapping of the left ventricle in the basal state and during extrastimuli, and programmed stimulation of the right and left ventricle including the simultaneous recording of the Purkinje system.
Follow-up will be performed for 3 years, looking for the occurrence of major arrhythmic events such as: 1) Appropriate therapy (for VT/VF) delivered by an ICD or 2) documented ventricular arrhythmia on ECG, implantable loop recorder or pacemaker or 3) Clinical sudden death.
- Conditions
- Ventricular Arrhythmia, Cardiomyopathies, Left Ventricular Ejection Fraction Less Then or Equal to 50percent
- Being tested
- Implantation of an ICD
- Keywords
- cardiomyopathies, sudden death, Myocardial Infarction
- Medical subject headings
- Cardiomyopathies, Death, Sudden, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of an ICDDevice
Implantation of an ICD
| Study group | Role | What they receive |
|---|---|---|
| Implantation of an ICD | Experimental | Patients implanted with an ICD Receives: Device: Implantation of an ICD |
| Clinical follow-up | No intervention | Patients not implanted with an ICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of major rhythmic events
Follow-up on Occurrence of major rhythmic events
Measured: 60 months
Secondary outcomes (3)
Surfaces distributions of abnormal ventricular potentials
Measured: Day 1
Spatial distributions of abnormal ventricular potentials
Measured: Day 1
Purkinje potentials in induced arrhythmias
Presence or absence
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start12 Jun 2023
- Primary completion12 Sep 2030 (estimated)
- Study completion12 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrhythmiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020702
- Sponsor's protocol ID
- CHUBX 2022/37
- Acronym
- EP-SCOPE
- Status last verified
- Jul 2025
- First submitted
- 5 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction
- ClinicalTrials.gov ID
- NCT07020702
- Acronym / sponsor ID
- EP-SCOPE / CHUBX 2022/37
- Conditions
- Ventricular Arrhythmia, Cardiomyopathies, Left Ventricular Ejection Fraction Less Then or Equal to 50percent
- Keywords
- cardiomyopathies, sudden death, Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 12 Sep 2030 (estimated)
- Study completion
- 12 Sep 2030 (estimated)
- First posted
- 13 Jun 2025 (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.
EP-SCOPE is a prospective, multicentric, non-randomized pilot study that aims to estimate the risk of life-threatening ventricular arrhythmia through use of advanced electrophysiological studies in patients with ischemic or non-ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) <50% and risk factors of ventricular arrhythmia, otherwise not considered for implantation of an implantable cardioverter defibrillator (ICD).
The objective is to assess the effectiveness of a risk stratification strategy based on detailed electrophysiological exploration of the left ventricle and programmed ventricular stimulation.
Detailed description
Responsible for 10% of deaths in the general population, sudden cardiac death is mostly caused by malignant ventricular arrhythmias (80%). These arrhythmias mainly occur in cardiomyopathies (75-90%). Currently, the prevention of sudden death is based on risk stratification according to the evaluation of myocardial contractility with indications for prophylactic ICD implantation reserved for LVEF ≤ 35%. This predictor is notoriously insufficient for several main reasons: 1) While ICDs are indicated in patients with LVEF ≤35%, only a minority (2 -5% per year) will suffer from arrhythmia and therefore benefits from ICD implantation, while all will be subject to potential complications. 2) The majority of sudden death (70-80%) occur in patients with LVEF >35%; while they have a lower arrhythmia risk (1-2% per year), they constitute a population four times larger, which is not stratified. 3) Finally, the cardiomyopathy population is broad, and include distinct clinical scenarios that are not specifically addressed.
While conventional electrophysiological studies only boast a limited number of measurements, the proposed strategy is a detailed electrophysiological characterization of the altered ventricle. Measurements include a detailed mapping of the left ventricle in the basal state and during extrastimuli, and programmed stimulation of the right and left ventricle including the simultaneous recording of the Purkinje system.
Follow-up will be performed for 3 years, looking for the occurrence of major arrhythmic events such as: 1) Appropriate therapy (for VT/VF) delivered by an ICD or 2) documented ventricular arrhythmia on ECG, implantable loop recorder or pacemaker or 3) Clinical sudden death.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implantation of an ICD | Experimental | Device: Implantation of an ICDPatients implanted with an ICD |
| Clinical follow-up | No intervention | –Patients not implanted with an ICD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with cardiomyopathy with 35%<LVEF<50% and at least one risk factor
- Patients with cardiomyopathy with LVEF≤35% and an indication for cardiac resynchronisation
Key exclusion criteria (10 listed)
- Patients who are minors or aged 80 or over
- Patients with unstable coronary artery disease
- Myocardial infarction less than 40 days old
- Coronary revascularisation <90 days
- Patients with intracardiac thrombus
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 |
|---|---|---|
| Implantation of an ICDImplantation of an ICD | Device | Implantation of an ICD |
Primary outcome
Occurrence of major rhythmic events
Time frame: 60 months
Follow-up on Occurrence of major rhythmic events
3 secondary outcomes
Surfaces distributions of abnormal ventricular potentials
Time frame: Day 1
Spatial distributions of abnormal ventricular potentials
Time frame: Day 1
Purkinje potentials in induced arrhythmias
Time frame: Day 1
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 10 Jul 2025.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of an ICD in people with Ventricular Arrhythmia and Cardiomyopathies, run by University Hospital, Bordeaux at 3 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 2 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 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Sylvain PLOUX, MD (+33(0)5 57 65 64 71, sylvain.ploux@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of major rhythmic events (time frame: 60 months). 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 10 Jul 2025.