ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction (EP-SCOPE)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiomyopathies; Ventricular Arrhythmia; Left Ventricular Ejection Fraction Less Then or Equal to 50percent
• Intervention / Treatment: Device: Implantation of an ICD

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 Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylvain PLOUX, MD; Phone Number: +33(0)5 57 65 64 71; Email: sylvain.ploux@chu-bordeaux.fr
• Study Contact Backup: Name: Mélissa LABEQUE; Phone Number: +33(0)5 57 62 31 32; Email: melissa.lavevre@chu-bordeaux.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Grégoire MASSOULLIE
    • Contact: Grégoire MASSOULLIE, MD; Phone Number: +33(0)4 73 75 14 10; Email: gmassoullie@chuclermontferrand.fr
  • Pessac, France, 33604
    • Recruiting
    • CHU de Bordeaux - Hôpital Cardiologique du Haut-Leveque
    • Contact: Mélissa LABEQUE; Phone Number: +33(0)5 57 62 31 32; Email: melissa.lavevre@chu-bordeaux.fr
    • Principal Investigator: Sylvain PLOUX
  • Saint-Etienne, France, 42270
    • Recruiting
    • CHU de Saint-Etienne
    • Contact: Karim BENALI, MD; Phone Number: +33(0)4 77 82 83 40; Email: karim.benali@chu-stetienne.fr
    • Principal Investigator: Karim BENALI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implantation of an ICD; Patients implanted with an ICD	Device: Implantation of an ICD; Implantation of an ICD
No Intervention: Clinical follow-up; Patients not implanted with an ICD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of major rhythmic events	Follow-up on Occurrence of major rhythmic events	60 months

Secondary Outcome Measures

Outcome Measure	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	Presence or absence	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): September 12, 2030
• Study Completion (Estimated): September 12, 2030

Study Registration Dates

• First Submitted: June 5, 2025
• First Submitted That Met QC Criteria: June 5, 2025
• First Posted (Actual): June 13, 2025

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Myocardial Infarction; cardiomyopathies; sudden death
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Heart Arrest; Death, Sudden; Cardiomyopathies; Death, Sudden, Cardiac; Death; Arrhythmias, Cardiac
• Other Study ID Numbers: CHUBX 2022/37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No