New Treatment of Cardiovascular Implantable Electronic Device (CIED) Infections; Immediate Reimplantation After Removal of Infected System

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 110
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Henning Bundgaard, MD, DMSc
henning.bundgaard@regionh.dk
35453534
Backup
Mia M Pries-Heje, MD, PhD
mia.marie.pries-heje.01@regionh.dk
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2037-12-31
Participants
Target number of participants: 176
Treatments
Experimental: Immediate reimplantation
Reimplantation in same procedure as removal of device or shortly thereafter.
Active_comparator: Standart care
Reimplantation of device in a second procedure at a later date, after infection has been stabilized/cleared
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov