Immediate reimplantation of cardiac devices after infection removal
Official title: New Treatment of Cardiovascular Implantable Electronic Device (CIED) Infections; Immediate Reimplantation After Removal of Infected System
Run by Copenhagen University Hospital, Rigshospitalet · NCT06250985 · Data updated 2026-11-12
This study is testing whether putting heart devices back in right away after an infection is safer and more effective than waiting to do it later for patients with endocarditis and device infections.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Enrollment | 176 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 5 sites (Frederiksberg, Copenhagen and 4 other locations) |
| Status | Recruiting |
| Started | April 29, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2037 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT06250985 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with confirmed infections of cardiac implantable electronic devices who meet specific stabilization criteria.
✕Probably not a fit
Patients with immunocompromised conditions or those experiencing septic shock may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of immediate reimplantation of cardiac electronic implantable devices in patients suffering from endocarditis and device infections. Participants will be randomly assigned to receive either immediate reimplantation or standard care, which involves reimplantation at a later date. The primary outcome will assess the occurrence of serious complications, including death, symptomatic embolism, bacteremia, or the need for device removal due to new infections within six months of randomization.
Why it matters
Potential benefit: If successful, this approach could reduce the risk of complications and improve outcomes for patients with cardiac device infections.
How similar studies have gone: Other studies have explored similar approaches, but this specific method of immediate reimplantation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Bispebjerg-Frederiksberg Hospital
Frederiksberg, Copenhagen, Denmark Recruiting -
Hilleroed Hospital
Hillerød, Nordsjaelland, Denmark Recruiting -
Aalborg University Hospital
Aalborg, North Denmark, Denmark Recruiting -
Rigshospitalet
Copenhagen, Denmark Recruiting -
Herlev-Gentofte Hospital
Herlev, Denmark Recruiting
Study contacts
- Principal investigator: Henning Henning — Copenhagen University Hospital, Rigshospitalet
- Study coordinator: Henning Bundgaard, MD, DMSc
- Email: henning.bundgaard@regionh.dk
- Phone: 35453534
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using bacteriophages with antibiotics to treat infective endocarditis
This study is testing whether using a special virus called bacteriophages along with antibiotics can help people with a serious heart infection called infective endocarditis.
-
Barts Endocarditis Registry
This registry collects health, imaging, microbiology, treatment, and outcome information from adults with infective endocarditis seen at Barts Heart Centre to learn which approaches work best.
-
Using fosfomycin to treat severely infected patients
This study is testing if an intravenous antibiotic called fosfomycin can safely help people with serious infections like osteomyelitis and bacterial meningitis feel better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.