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RECRUITING
NCT06250985
PHASE3

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

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 110 Years

Study Type

INTERVENTIONAL

Enrollment

176

Start Date

2024-04-29

Completion Date

2037-12-31

Last Updated

2025-10-08

Healthy Volunteers

No

Interventions

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

Locations (1)

Rigshospitalet

Copenhagen, Denmark