NCT06250985

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

New Treatment of Cardiovascular Implantable Electronic Device (CIED) Infections; Immediate Reimplantation After Removal of Infected System

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-04-29
• Primary completion: 2027-12-31
• Completion: 2037-12-31
• First posted: 2024-02-09
• Last updated: 2025-10-08

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study