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

University Hospital of Bordeaux

Status: Enrolling

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

Treatments: Device: Implantation of an ICD

Study type: Interventional

Funder types: Other

Identifiers

NCT07020702

CHUBX 2022/37

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Implantation of an ICD

Experimental group

Description:

Patients implanted with an ICD

Treatment:

Device: Implantation of an ICD

Clinical follow-up

No Intervention group

Description:

Patients not implanted with an ICD