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

Phase 3RecruitingNCT06250985

Rigshospitalet, Denmark176 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

176

Conditions

Endocarditis, Bacterial

Interventions

Timing of reimplantation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 110 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: within 6 months of randomization

Central Contacts

Henning Bundgaard, MD, DMSc

CONTACT

35453534 henning.bundgaard@regionh.dk

Mia M Pries-Heje, MD, PhD