Observational Study of ICD Replacement for Preventing Sudden Cardiac Death in Heart Failure Patients

What this Trial Is About

This research aims to better understand and identify patients at high risk of sudden cardiac death SCD by studying subtle structural and functional heart abnormalities, some of which may be genetically determined. The study focuses on patients with cardiomyopathy who have implantable cardioverter defibrillators ICDs placed for primary prevention of SCD. It observes patients who receive ICD pulse generator replacements to explore biological, genetic, and clinical markers linked to SCD risk. Patients in this observational study undergo ICD implantation according to current standards for primary prevention of SCD. The ICD settings are standardized to detect rapid ventricular tachycardia or fibrillation, with device interrogations every three months. Blood samples, digital electrocardiograms, and other clinically indicated tests are collected at six-month intervals. Follow-up includes detailed monitoring of ICD firings and clinical events such as heart failure or myocardial infarction. Participants are evaluated at regular visits every three to six months over at least ten years or until death, heart transplantation, or ventricular assist device implantation. Information gathered includes genetic, proteomic, ECG, and imaging markers. The primary outcome is an appropriate ICD firing for rapid ventricular arrhythmias. Safety data and clinical care remain under the management of the treating physicians, with critical findings promptly communicated. The study also examines long-term changes and additional markers to improve risk stratification for these patients.

Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention