About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Implantation of an ICD
DeviceImplantation of an ICD
Treatment groups
Trial outcomes
Primary outcomes
Occurrence of major rhythmic events
Follow-up on Occurrence of major rhythmic events
Secondary outcomes
Surfaces distributions of abnormal ventricular potentials
Spatial distributions of abnormal ventricular potentials
Purkinje potentials in induced arrhythmias
Presence or absence
Sponsors and contacts
Click on the lead sponsor to view all of their trials.