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NCT Number: NCT06250985

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

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

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Key information

Conditions

Endocarditis, Bacterial Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Cardiovascular Infections Endocarditis Heart Diseases Infections

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Timing of reimplantation

Other

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Henning Bundgaard, MD, DMSc

CONTACT

[email protected]

35453534

Mia M Pries-Heje, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: POET-PPM

Important dates

Study start
2024
Primary completion
2027
Study completion
2037
First posted
Feb 9, 2024
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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