Electrophysiological mapping to predict sudden cardiac death risk
Official title: ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction
Run by University Hospital, Bordeaux · NCT07020702 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 3 sites (Clermont-Ferrand and 2 other locations) |
| Status | Recruiting |
| Started | June 12, 2023 |
| Main results expected | September 12, 2030 |
| Study ends | September 12, 2030 |
| Registry record updated | July 10, 2025 |
| Trial ID | NCT07020702 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.