ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction
Recruiting now · Not applicable
Conditions studied: Ventricular Arrhythmia, Cardiomyopathies, Left Ventricular Ejection Fraction Less Then or Equal to 50percent
In brief
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.
Key facts
- Study ID
- NCT07020702
- Run by
- University Hospital, Bordeaux
- People needed
- 210
- Starts
- 2023-06-12
- Expected to finish
- 2030-09-12
- Last updated by the study team
- 2025-07-10
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (enrolling)
- CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévêque — Pessac, France (enrolling)
- CHU de Saint-Etienne — Saint-Etienne, France (enrolling)
Full record on ClinicalTrials.gov
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