ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implantation of an ICD.
- Who it may be relevant to
- Registry conditions: Ventricular Arrhythmia, Cardiomyopathies, Left Ventricular Ejection Fraction Less Then or Equal to 50percent. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Implantation of an ICD
Implantation of an ICD
Primary outcome measures
- Occurrence of major rhythmic events [Time frame: 60 months]
Secondary outcome measures (3)
- Surfaces distributions of abnormal ventricular potentials [Time frame: Day 1]
- Spatial distributions of abnormal ventricular potentials [Time frame: Day 1]
- Purkinje potentials in induced arrhythmias [Time frame: Day 1]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 3 centers
- CHU de Clermont-Ferrand — Clermont-Ferrand
- CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévêque — Pessac
- CHU de Saint-Etienne — Saint-Etienne
Identifiers
NCT: NCT07020702 · CHUBX 2022/37