Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT06203769
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Diagnosis of CIED leads infections, defined by:
1. Symptoms/signs of systemic infection AND positive blood cultures fulfilled the major Duke microbiological criteria AND echocardiography consistent with vegetation(s) attached to lead(s) AND/OR \[18F\]FDG PET/CT or radiolabelled WBC SPECT/CT detection of abnormal activity along leads OR
2. Symptoms/signs of systemic infection AND NO, signs of generator pocket infection, AND culture, histology or molecular evidence of infection on explanted lead.
* Complete removal of the infected CIED
* Signed informed consent
* French National Health Assurance
Exclusion Criteria:
* Current involvement of native or prosthetic heart valve
* Distant infectious foci (such as haematogenous vertebral osteomyelitis, pulmonary abscess…) justifying a prolonged duration of therapy.
* Positive blood culture \> 24 hours after cultures despite CIED removal
* CIED infection with Mycobacteria or Fungi
* Women who are pregnant or nursing
* Females of childbearing potential without effective method of birth control
* Patients who are under tutorship or curatorship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06203769
Study Brief:
Protocol Section:
NCT06203769