ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction

NCT07020702 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Bordeaux

Phase

Not applicable

Started

2023-06-12

Last updated

2025-07-10

Condition(s) studied

Ventricular ArrhythmiaCardiomyopathiesLeft Ventricular Ejection Fraction Less Then or Equal to 50percent

Investigational drug(s) / intervention(s)

Implantation of an ICD

Implantation of an ICD: Implantation of an ICD

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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 outcome measure(s)

Occurrence of major rhythmic events — 60 months
Follow-up on Occurrence of major rhythmic events

Trial sites (3)

Facility	City	Region	Status
CHU de Clermont-Ferrand	Clermont-Ferrand	France	Recruiting
CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévêque	Pessac	France	Recruiting
CHU de Saint-Etienne	Saint-Etienne	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07020702 on ClinicalTrials.gov ↗ ← All trials in France