New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-110
SponsorCopenhagen University Hospital, Rigshospitalet

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Timing of reimplantation

    Other intervention

    Patients will be rendomized 1:1 by computer to recieve either standart care or intervention prior to removal of infected system

Treatment groups

176 Participants
are divided into 2 treatment groups
Group A: Immediate reimplantationExperimental treatment 1 intervention
Group B: Standart careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite primary outcome

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.

Time frame
within 6 months of randomization

Secondary outcomes

Other outcomes

Sponsors and contacts

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