New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected Sy… (NCT06250985) | Clinical Trial Compass
RecruitingPhase 3
New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System
Denmark176 participantsStarted 2024-04-29
Plain-language 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
Who can participate
Age range
18 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.