ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction
University Hospital, Bordeaux
210 participants
Jun 12, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria10
- 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
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Interventions
Implantation of an ICD
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT07020702