New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System
Recruiting now · Phase 3
Conditions studied: Endocarditis, Bacterial
In brief
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
Key facts
- Study ID
- NCT06250985
- Run by
- Rigshospitalet, Denmark
- People needed
- 176
- Starts
- 2024-04-29
- Expected to finish
- 2037-12-31
- Last updated by the study team
- 2025-10-08
Who can join
Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- A minimum of 3 days of sufficient antibiotic treatment (intravenous or oral) has been administered and/or culture negative antibiotic regimen have been adminstered until blood culture is examined.
- 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.
You may not qualify if…
- 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
Where it is running
- Rigshospitalet — Copenhagen, Denmark (enrolling)
Full record on ClinicalTrials.gov
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