Overview
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
Inclusion Criteria:
- Culture positive or negative infection of a CIED acording to PI
- Indication for removal of device
- Indictation for reimplantation of new device
- A minimum of 3 days of sufficient antibiotic treatment (intravenous or oral) has been administered
- stabilization criteria fulfilled i.e. I) negativ blood cultures, II) WBC < 15 mia/L or reduction of min. 25% and III) CRP <50 or min. 25% reduction.
Exclusion Criteria:
- 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