ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction

NCT07020702 | Recruiting

• 1 other identifier: CHUBX 2022/37
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

cardiomyopathies; sudden death; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Occurrence of major rhythmic events

  Follow-up on Occurrence of major rhythmic events

  60 months

Secondary Outcomes (3)

• Surfaces distributions of abnormal ventricular potentials

  Day 1

• Spatial distributions of abnormal ventricular potentials

  Day 1

• Purkinje potentials in induced arrhythmias

  Day 1

Study Arms (2)

Implantation of an ICD

EXPERIMENTAL

Patients implanted with an ICD

Device: Implantation of an ICD

Clinical follow-up

NO INTERVENTION

Patients not implanted with an ICD

Interventions

Implantation of an ICD DEVICE

Implantation of an ICD

Implantation of an ICD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (3)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévêque

Pessac, 33604, France

RECRUITING

CHU de Saint-Etienne

Saint-Etienne, 42270, France

RECRUITING

MeSH Terms

Conditions

Cardiomyopathies; Death, Sudden; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: June 12, 2023
• Primary Completion (Estimated): September 12, 2030
• Study Completion (Estimated): September 12, 2030
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

FR (3)