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

Condition(s) studied

Investigational drug(s) / intervention(s)

Timing of reimplantation: Patients will be rendomized 1:1 by computer to recieve either standart care or intervention prior to removal of infected system

Study summary

The goal of this randomized clinical trials is to ascertain the safety and efficacy of immediate reimplantation of cardiac electronic implantable devices in patients with endocarditis and device-infections, compared to standard care, i.e. reimplantation at a later procedure date.

The primary outcome is the occurence of the composite primary endpoint within 6 months of randomization consisting of

* Death
* Symptomatic embolism (systemic arterial embolism or pulmonary embolism)
* Bacteremia og pocket-infection
* Removal of a CIED due to new infection

Eligibility

Primary outcome measure(s)

• Composite primary outcome — within 6 months of randomization
  Composite endpoint consisting of number of participants with one or more of the following events during follow-up: death, symptomatic embolism (systemic or pulmonary), bacteremia or pocket infection with same bacterial pathogen or removal of device due to new infection.

Trial sites (5)

More Copenhagen University Hospital, Rigshospitalet trials in Denmark