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

NCT06250985 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2025-10-08

No results posted yet for this 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

Conditions

  • Endocarditis, Bacterial

Interventions

OTHER

Timing of reimplantation

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

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Henning Henning · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2027-12-31
Completion
2037-12-31
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06250985 on ClinicalTrials.gov