ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévêque
RECRUITING
Pessac
CHU de Saint-Etienne
RECRUITING
Saint-etienne
Contact Information
Primary
Sylvain PLOUX, MD
sylvain.ploux@chu-bordeaux.fr
+33(0)5 57 65 64 71
Backup
Mélissa LABEQUE
melissa.lavevre@chu-bordeaux.fr
+33(0)5 57 62 31 32
Time Frame
Start Date: 2023-06-12
Estimated Completion Date: 2030-09-12
Participants
Target number of participants: 210
Treatments
Experimental: Implantation of an ICD
Patients implanted with an ICD
No_intervention: Clinical follow-up
Patients not implanted with an ICD
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov