Actively Recruiting
New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System
Led by Rigshospitalet, Denmark · Updated on 2025-10-08
176
Participants Needed
1
Research Sites
713 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Culture positive or negative infection of a cardiac implantable electronic device (CIED) according to principal investigator
- Indication for removal of the infected device
- Clinical indication for removal of the existing device (concurrent left-sided infective endocarditis is allowed)
- Indication for reimplantation of a new device
- At least 3 days of sufficient antibiotic treatment (intravenous or oral) administered or culture-negative antibiotic regimen until blood culture examination
- Stabilization criteria met: negative blood cultures, white blood cell count below 15 million/L or reduced by at least 25%, and C-reactive protein below 50 or reduced by at least 25%
You will not qualify if you...
- Immunodeficiency due to active chemotherapy or prednisone treatment over 20 mg/day
- Device infection within the last 6 months (relapse)
- Presence of septic shock
- Stabilization criteria not met after 10 days of sufficient antibiotic treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
H
Henning Bundgaard, MD, DMSc
CONTACT
M
Mia M Pries-Heje, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here