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

RecruitingPhase 3Ages 18 Years - 110 YearsAllCopenhagen University Hospital, Rigshospitalet
NCT06250985 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. 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
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What it tests

  • Timing of reimplantation
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Where

5 sites
Bispebjerg-Frederiksberg Hospital
Frederiksberg, Denmark
Hilleroed Hospital
Hillerød, Denmark
Aalborg University Hospital
Aalborg, Denmark
Rigshospitalet
Copenhagen, Denmark
Herlev-Gentofte Hospital
Herlev, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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