Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantation of an ICD | Experimental | Patients implanted with an ICD |
|
| Clinical follow-up | No Intervention | Patients not implanted with an ICD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of an ICD | Device | Implantation of an ICD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of major rhythmic events | Follow-up on Occurrence of major rhythmic events | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surfaces distributions of abnormal ventricular potentials | Day 1 | |
| Spatial distributions of abnormal ventricular potentials | Day 1 | |
| Purkinje potentials in induced arrhythmias |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylvain PLOUX, MD | Contact | +33(0)5 57 65 64 71 | sylvain.ploux@chu-bordeaux.fr | |
| Mélissa LABEQUE | Contact | +33(0)5 57 62 31 32 | melissa.lavevre@chu-bordeaux.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Presence or absence |
| Day 1 |
| CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévêque | Recruiting | Pessac | 33604 | France |
|
| CHU de Saint-Etienne | Recruiting | Saint-Etienne | 42270 | France |
|
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D003645 | Death, Sudden |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
Not provided
Not provided