ClinicalTrials.gg
RecruitingNCT06250985POET-PPMUpdated Oct 1, 2026

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

A Phase 3 interventional study of Timing of reimplantation in Endocarditis, Bacterial, sponsored by Copenhagen University Hospital, Rigshospitalet. Recruiting at 5 sites in Denmark. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Updated Oct 1, 2026Sponsor changed4 sites addedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
176
Allocation
Randomized
Ages
18 Years to 110 Years
Sex
All
01

Study 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
02

Conditions studied

  • Endocarditis, Bacterial
03

In context

Endocarditis, Bacterial

22 studies on the registry are indexed under Endocarditis, Bacterial; 9 are open to participants now.

This study's planned enrollment of 176 is above the median of 38 across 11 interventional studies indexed under Endocarditis, Bacterial.

Browse Endocarditis, Bacterial studies →

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 42 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ).
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
176 participants (estimated)

Study arms

  • Experimental
    Immediate reimplantation

    Reimplantation in same procedure as removal of device or shortly thereafter.

    Other: Timing of reimplantation

  • Active comparator
    Standart care

    Reimplantation of device in a second procedure at a later date, after infection has been stabilized/cleared

    Other: Timing of reimplantation

Interventions

  • OtherTiming of reimplantation

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

06

What researchers measure

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

07

Study locations

5 of 5 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
4 sites added
Show 4 added (4 Denmark)
  • Bispebjerg-Frederiksberg Hospital · Frederiksberg, Denmark
  • Hilleroed Hospital · Hillerød, Denmark
  • Aalborg University Hospital · Aalborg, Denmark
  • Herlev-Gentofte Hospital · Herlev, Denmark
Oct 1, 2026
Sponsor
Rigshospitalet, Denmark→Copenhagen University Hospital, Rigshospitalet
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    4 sites added
    Show 4 added (4 Denmark)
    • Bispebjerg-Frederiksberg Hospital · Frederiksberg, Denmark
    • Hilleroed Hospital · Hillerød, Denmark
    • Aalborg University Hospital · Aalborg, Denmark
    • Herlev-Gentofte Hospital · Herlev, Denmark
    Sponsor Rigshospitalet, Denmark→Copenhagen University Hospital, Rigshospitalet
    + 4 other changes: identifiers, verification date, oversight details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06250985
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Responsible party
Henning Bundgaard (Professor, Copenhagen University Hospital, Rigshospitalet) — Principal investigator
First posted
Feb 9, 2024
Start date
Apr 29, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2037 (estimated)
Last update
Oct 1, 2026

Study contacts

Henning Bundgaard, MD, DMSc
Contact
henning.bundgaard@regionh.dk
35453534
Mia M Pries-Heje, MD, PhD
Contact
mia.marie.pries-heje.01@regionh.dk
Henning Henning
principal investigator · Copenhagen University Hospital, Rigshospitalet

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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