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

Save

Report Abuse

Description

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

Targeted Conditions

Study Overview

Start Date
February 1, 2024
Completion Date
December 31, 2037
Enrollment
176
Date Posted
February 9, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Rigshospitalet
Copenhagen 2100, Denmark

Eligibility

Minimum Age (years)
18
Maximum Age (years)
110
Eligibility Criteria
Inclusion Criteria:

Culture positive or negative infection of a CIED acording to PI
Indication for removal of device
Indictation for reimplantation of new device
A minimum of 3 days of sufficient antibiotic treatment (intravenous or oral) has been administered
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

Study Contact Info

Study Contact Name
Henning Bundgaard, MD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System 0 reviews

Write Your Review

There are no reviews yet.

Write Your Review

Your email address will not be published. Required fields are marked *

Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
NCTid (if applicable)
NCT06250985