ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction

NCT ID: NCT07020702

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-12
• Study Completion Date: 2030-09-12

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.

Conditions

Ventricular Arrhythmia; Cardiomyopathies; Left Ventricular Ejection Fraction Less Then or Equal to 50percent

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Implantation of an ICD

Patients implanted with an ICD

Group Type: EXPERIMENTAL

Implantation of an ICD

Intervention Type: DEVICE

Implantation of an ICD

Clinical follow-up

Patients not implanted with an ICD

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Implantation of an ICD

Implantation of an ICD

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévêque

Pessac, , France

Site Status: RECRUITING

CHU de Saint-Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sylvain PLOUX, MD

Role: CONTACT

sylvain.ploux@chu-bordeaux.fr

+33(0)5 57 65 64 71

Mélissa LABEQUE

Role: CONTACT

melissa.lavevre@chu-bordeaux.fr

+33(0)5 57 62 31 32

Facility Contacts

Grégoire MASSOULLIE, MD

Role: primary

gmassoullie@chuclermontferrand.fr

+33(0)4 73 75 14 10

Mélissa LABEQUE

Role: primary

melissa.lavevre@chu-bordeaux.fr

+33(0)5 57 62 31 32

Karim BENALI, MD

Role: primary

karim.benali@chu-stetienne.fr

+33(0)4 77 82 83 40

Other Identifiers

CHUBX 2022/37

Identifier Type: -

Identifier Source: org_study_id