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NCT Number: NCT07020702

ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of an ICD

Device

Implantation of an ICD

Primary outcomes

  1. Occurrence of major rhythmic events

    Time frame: 60 months

    Follow-up on Occurrence of major rhythmic events

Secondary outcomes

  1. Surfaces distributions of abnormal ventricular potentials

    Time frame: Day 1

  2. Spatial distributions of abnormal ventricular potentials

    Time frame: Day 1

  3. Purkinje potentials in induced arrhythmias

    Time frame: Day 1

    Presence or absence

Study contacts

Contact information is provided by the study sponsor or research team.

Mélissa LABEQUE

CONTACT

[email protected]

+33(0)5 57 62 31 32

Sylvain PLOUX, MD

CONTACT

[email protected]

+33(0)5 57 65 64 71

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: EP-SCOPE

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jun 13, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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