Immediate reimplantation of cardiac devices after infection removal
New Treatment of Cardiovascular Implantable Electronic Device (CIED) Infections; Immediate Reimplantation After Removal of Infected System
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 |
| Enrollment | 176 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06250985 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed infections of cardiac implantable electronic devices who meet specific stabilization criteria.
Not a fit: Patients with immunocompromised conditions or those experiencing septic shock may not benefit from this study.
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 performed: Other studies have explored similar approaches, but this specific method of immediate reimplantation is relatively novel.
Eligibility criteria
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 this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Henning Henning — Rigshospitalet, Denmark
- Study coordinator: Henning Bundgaard, MD, DMSc
- Email: henning.bundgaard@regionh.dk
- Phone: 35453534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.