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

Study acronym: POET-PPM
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Lead sponsor: Rigshospitalet, Denmark to Copenhagen University Hospital, Rigshospitalet
    • Trial sites expanded: 1 → 5 locations
    • Eligibility criteria shortened, about 15 words
  2. Start date changed from estimate of Apr 1, 2024 to Apr 29, 2024
    • Eligibility criteria expanded, about 28 words
    v3
  3. Start date: Feb 1, 2024 to Apr 1, 2024
    • Primary endpoint revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06250985
Lead Sponsor Copenhagen University Hospital, Rigshospitalet
Conditions
(from sponsor)		 Endocarditis, Bacterial
Related terms Endocarditis, Bacterial
Enrollment 176 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov