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Heart device infection? new study tests immediate replacement

NCT ID NCT06250985

Disease control Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether replacing an infected heart device immediately after removal is as safe and effective as waiting for a later procedure. About 176 adults with device infections will be randomly assigned to either immediate or delayed reimplantation. The main goal is to see if immediate replacement leads to fewer serious events like death, blood infections, or new device infections within six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
timing of reimplantation (immediate vs. standard delayed)
What this could lead to
If successful, this could allow patients with infected heart devices to get a new device sooner, reducing hospital stays and risks from waiting.
What could go wrong
This is a phase 3 trial with 176 participants, so results are not yet proven. Immediate reimplantation may increase the risk of reinfection or other complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 176 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Dec 2037

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 110 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bacterial endocarditis endocarditis infective endocarditis prosthesis-related infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endocarditis, bacterial

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

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