Cardioverter Defibrillator Placement for Primary Prevention of Sudden Cardiac Death in Patients Older Than 70 Years: A Randomized Controlled Trial

What this Trial Is About

This research aims to evaluate the use of implantable cardioverter defibrillators (ICD) for preventing sudden cardiac death in patients aged 70 years and older who have an ICD indication for primary prevention. It specifically compares whether heart failure optimal therapy alone (HFOT) is not worse than combining HFOT with ICD implantation regarding overall survival at 48 months after randomization. The study addresses the lack of clear evidence about the benefit of ICDs in the elderly and seeks to understand if avoiding ICD implantation can reduce device-related complications and healthcare costs. Participants are randomly assigned to one of two groups: one group receives heart failure optimal therapy without ICD implantation, and the other receives optimal medical therapy plus ICD implantation. ICD devices used are any CE-marked brand available and reimbursed in the French market, implanted at the discretion of the local investigator. The study follows patients for four years after randomization, monitoring survival and health outcomes. During the study, participants undergo regular assessments including heart failure evaluations and quality of life questionnaires at multiple intervals up to 48 months. Researchers measure overall survival as the primary outcome and track cardiovascular mortality, sudden cardiac death, hospitalizations, ICD-related complications, and quality of life scores as secondary outcomes. The trial includes follow-up visits to monitor health status, treatment adherence, and complications to provide comprehensive data on the long-term impact of these treatment strategies.

Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years