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Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment

NCT06323668 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-11-20

No results posted yet for this study

Summary

The CIEDOUT study is an open label randomized trial in patients with possible cardiac implantable electronic device (CIED) infection.

The hypothesis is that CIED removal + guideline antibiotic therapy is better than 6-weeks antibiotic therapy alone in preventing death or relapse of bacteremia in patients with bacteremia and possible CIED infection (not definite CIED infection).

The objective of this study is to test whether CIED removal + guideline antibiotic therapy is superior to 6-weeks antibiotic therapy alone in prevention of the composite endpoint of death or relapse bacteremia after 6 months of follow-up in patients with CIED and systemic infection but without definite CIED infection.

Conditions

  • Cardiac Implantable Electronic Device Infection

Interventions

PROCEDURE

Cardiac implantable electronic device extraction

The CIED removal will be done as soon as possible within 7 days.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Emil L Fosbøl, MD, PhD · Department of Cardiology, Copenhagen University Hospital, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-17
Primary Completion
2028-06-30
Completion
2038-01-31

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 NCT06323668 on ClinicalTrials.gov