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Assessment of Diagnostic and Therapeutic Practices for Cardiac Implantable Electronic Devices Suspected Infections in Nancy University Hospital

Assessment of Diagnostic and Therapeutic Practices for Cardiac Implantable Electronic Devices Suspected Infections in Nancy University Hospital

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04501835
Enrollment
184
Registered
2020-08-06
Start date
2019-07-31
Completion date
2020-09-30
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Implantable Electronic Device Infections

Brief summary

The frequency of cardiac implantable electronic devices (CIED) is constantly increasing. Devices infections are one of the most serious complications in terms of morbidity and mortality. Although the frequency of cardiac implantable devices infections is difficult to derminate due to divergent definitions, cohort studies report a trend of increasing. The infection can be localized at the pocket of the implantation, at intravascular or intra-cardiac portion of leads. Infectious endocarditis defined by involvement of the intra-cardiac portion of leads is the most serious form. The diagnosis is based on clinical, biological and multimodal imagery data. Early diagnosis and specific management are necessary to reduce mortality and morbidity. Since the last European recommendations on infectious endocarditis in 2015, the HeartRythm Society of patient described an algorithm to treat CIED infections and extraction indications. However, in practice, management of CEID infections remains center-dependent and data from robust international studies are missing. The main objective of our study is to evaluate the management of CEID suspected infections and the prognosis at 1 year in terms of survival according to the methods of treatment at the Nancy University Hospital and to compare the treatment with the latest recommendations in force

Interventions

OTHERDiagnostic and treatment evaluation

No intervention, description of the diagnostic evaluation and the treatment

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients who have been hospitalized in Nancy University Hospital between January 2014 et July 2019 for suspected infection of cardiac implantable electronic device

Exclusion criteria

* Minor patients * Epicardial CIED

Design outcomes

Primary

MeasureTime frameDescription
Description of the practiceFrom January 2014 to July 2020Describe the diagnostic and therapeutic practices of patients hospitalized for CIED suspected infection

Secondary

MeasureTime frameDescription
Evaluation of local practices against current recommendationsFrom January 2014 to July 2020* Classify patients in 3 groups (1 = Cardiac implantable electronic device infection ; 2 Pocket infection without proof of lead involvements ; 3 = systemic infection related to infective valvular endocarditis or not without proof of lead involvements according to our local practices and criteria, to EHRA criteria and modified Duke Li criteria). * Compare diagnostic management in our center with EHRA recommendations in each groups * Compare therapeutic management including removal/extraction of cardiac implantable electronic device, antibiotic therapy * Assessment of adhering to EHRA recommendations * Pronostic evaluation according to removal/extraction or not based on survival curve

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026