New Treatment Approach for Cardiac Electronic Device Infections Comparing Immediate Versus Delayed Reimplantation After Removal

What this Trial Is About

Researchers are evaluating the safety and effectiveness of immediate reimplantation of cardiac electronic implantable devices CIEDs in patients with endocarditis and device infections. This phase 3 randomized clinical trial compares immediate reimplantation during the same procedure as device removal or shortly after, to the standard care of reimplantation at a later date once the infection has been stabilized or cleared. The study focuses on serious outcomes within 6 months after randomization, including death, symptomatic embolism, bacteremia or pocket infection, and device removal due to new infection. Participants are randomly assigned to one of two groups one group receives immediate reimplantation of the device, and the other group follows standard care with reimplantation at a later procedure date. Both groups undergo removal of the infected device and receive antibiotic treatment. The study requires participants to meet stabilization criteria before reimplantation, including negative blood cultures and improvements in white blood cell count and C-reactive protein levels. During the trial, participants are monitored closely with clinical assessments to track infection status and complications. Researchers will measure the occurrence of the composite primary endpoint within 6 months of randomization. The total study duration includes follow-up to observe safety and infection outcomes. Participants health is carefully evaluated throughout the trial to assess the impact of the timing of device reimplantation on infection control and overall survival.

New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System