Electrophysiological Study to Predict Sudden Cardiac Death in Patients with Cardiomyopathy and Reduced Heart Function

What this Trial Is About

Researchers are studying patients with cardiomyopathy and left ventricular ejection fraction below 50% who have risk factors for ventricular arrhythmia but are not currently recommended for an implantable cardioverter defibrillator ICD. This prospective, multicenter pilot study aims to estimate the risk of life-threatening ventricular arrhythmias by using advanced electrophysiological studies to better predict sudden cardiac death. The study evaluates a risk stratification strategy based on detailed electrophysiological exploration of the left ventricle and programmed ventricular stimulation. The study includes two groups patients implanted with an ICD and those who are not. The intervention involves detailed mapping of the left ventricle under baseline and stimulated conditions, programmed ventricular stimulation of both ventricles, and simultaneous recording of the Purkinje system to characterize arrhythmia substrates. The follow-up period lasts for three years to monitor major arrhythmic events including ICD therapies, documented ventricular arrhythmias, or sudden cardiac death. Participants will undergo detailed electrophysiological testing on the first day and will be followed over 60 months to record major rhythmic events. Researchers will assess abnormal ventricular potentials and Purkinje potentials during induced arrhythmias. Monitoring includes ECG, implantable loop recorders, or pacemaker data, alongside clinical evaluations. The study measures outcomes related to the occurrence and spatial distribution of arrhythmias, with safety and long-term follow-up included.

ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction