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OpenTrials
Completed

NCT Number: NCT04501835

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

De Ciancio

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic and treatment evaluation

Other

No intervention, description of the diagnostic evaluation and the treatment

Primary outcomes

  1. Description of the practice

    Time frame: From January 2014 to July 2020

    Describe the diagnostic and therapeutic practices of patients hospitalized for CIED suspected infection

Secondary outcomes

  1. Evaluation of local practices against current recommendations

    Time frame: From 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2020
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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