About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Culture positive or negative infection of a CIED acording to PI
Indication for removal of device
Clinical indication of device removal of existing device (concurrent left-sided IE is not a contraindication).
Indication for reimplantation of new device
Disqualifiers
Immunoincompetence (active chemotherapy or prednisone treatment > 20mg/day
Device-infection within last 6 months (relaps)
Septic shock
Stabilization criteria not fulfilled after 10 days of suficient antibiotic treatment
Trial design
Parallel
Treatments tested in this trial
Timing of reimplantation
Other interventionPatients will be rendomized 1:1 by computer to recieve either standart care or intervention prior to removal of infected system
Treatment groups
Trial outcomes
Primary outcomes
Composite primary outcome
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.
Sponsors and contacts
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