New Treatment of Cardiovascular Implantable Electronic Device (CIED) Infections; Immediate Reimplantation After Removal of Infected System
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Endocarditis, Bacterial
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- Composite primary outcome
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
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
Investigators
Henning Bundgaard
Professor
Rigshospitalet, Denmark
Eligibility 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
Outcomes
Primary Outcomes
Composite primary outcome
Time Frame: within 6 months of randomization
Composite endpoint consisting of number of participants with one or more of the following events during follow-up: death, symptomatic embolism (systemic or pulmonary), bacteremia or pocket infection with same bacterial pathogen or removal of device due to new infection.