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

NCT ID: NCT06250985

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2037-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate reimplantation

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

Group Type: EXPERIMENTAL

Timing of reimplantation

Intervention Type: OTHER

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

Standart care

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

Group Type: ACTIVE_COMPARATOR

Timing of reimplantation

Intervention Type: OTHER

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

Interventions

Timing of reimplantation

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Henning Bundgaard

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henning Henning

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Henning Bundgaard, MD, DMSc

Role: CONTACT

henning.bundgaard@regionh.dk

35453534

Mia M Pries-Heje, MD, PhD

Role: CONTACT

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

Facility Contacts

Henning Bundgaard, MD

Role: primary

Henning.Bundgaard@Regionh.DK

+45 3545 0512

Other Identifiers

H-23033548

Identifier Type: -

Identifier Source: org_study_id