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

NCT06250985 | Recruiting Phase 3 FDA Device

• 1 other identifier: H-23033548
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Composite primary outcome

  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.

  within 6 months of randomization

Study Arms (2)

Immediate reimplantation

EXPERIMENTAL

Reimplantation in same procedure as removal of device or shortly thereafter.

Other: Timing of reimplantation

Standart care

ACTIVE COMPARATOR

Reimplantation of device in a second procedure at a later date, after infection has been stabilized/cleared

Other: Timing of reimplantation

Interventions

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

Immediate reimplantation; Standart care

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Endocarditis, Bacterial

Condition Hierarchy (Ancestors)

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

Study Officials

• Henning Henning

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henning Bundgaard, MD, DMSc

CONTACT

35453534; henning.bundgaard@regionh.dk

Mia M Pries-Heje, MD, PhD

CONTACT

mia.marie.pries-heje.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: April 29, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2037
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)