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ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction

RECRUITINGN/ASponsored by University Hospital, Bordeaux
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Bordeaux
Started2023-06-12
Est. completion2030-09-12
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07020702

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions4

CardiomyopathiesHeart DiseaseLeft Ventricular Ejection Fraction Less Then or Equal to 50percentVentricular Arrhythmia

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