Electrophysiological mapping to predict sudden cardiac death risk
ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction
It will test whether detailed electrical mapping of the left ventricle can better predict dangerous ventricular arrhythmias in adults with ischemic or non-ischemic cardiomyopathy and LVEF under 50% who are not already ICD candidates.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 3 sites (Clermont-Ferrand and 2 other locations) |
| Trial ID | NCT07020702 on ClinicalTrials.gov |
What this trial studies
EP-SCOPE is a prospective, multicenter, non-randomized pilot that performs detailed invasive electrophysiological characterization of the left ventricle and programmed ventricular stimulation. Investigators will map the left ventricle at baseline and during extrastimulation, record Purkinje activity, and perform programmed stimulation of both ventricles. Patients will be followed for three years to record life-threatening ventricular arrhythmias and outcomes including ICD implantation. The aim is to develop a risk-stratification strategy that goes beyond LVEF alone to identify patients at higher arrhythmic risk.
Who should consider this trial
Good fit: Adults (under 80) with ischemic or non-ischemic cardiomyopathy and either LVEF 35–50% with at least one arrhythmic risk factor or LVEF ≤35% with an indication for cardiac resynchronization who are not already implanted with an ICD.
Not a fit: Patients with unstable coronary disease, recent myocardial infarction or revascularisation, intracardiac thrombus, mechanical heart valves, existing ICDs, life expectancy under one year, pregnancy, breastfeeding, or on disallowed antiarrhythmic drugs are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could better identify patients who truly need an ICD and reduce unnecessary device implants while preventing sudden cardiac death.
How similar studies have performed: Conventional electrophysiology and programmed stimulation have shown mixed predictive value, and detailed left ventricular substrate mapping with Purkinje recordings is a newer approach with promising but not yet widely validated results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clermont-Ferrand and 2 other locations
- 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)
Study contacts
- Study coordinator: Sylvain PLOUX, MD
- Email: sylvain.ploux@chu-bordeaux.fr
- Phone: +33(0)5 57 65 64 71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.