Clinical trial NCT07020702: ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction
Official title: ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventricular Arrhythmia
Cardiomyopathies
Left Ventricular Ejection Fraction Less Then or Equal to 50percent
Keywords: cardiomyopathies
sudden death
Myocardial Infarction
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Occurrence of major rhythmic events
timeFrame: 60 months
Secondary outcomes:
measure: Surfaces distributions of abnormal ventricular potentials
timeFrame: 1 day
measure: Spatial distributions of abnormal ventricular potentials
timeFrame: 1 day
measure: Purkinje potentials in induced arrhythmias
timeFrame: 1 day
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Pessac
country: France
facility: CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévêque
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
References: