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

January 26, 2021 updated by: Central Hospital, Nancy, France

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54500
        • De Ciancio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in Nancy University Hospital between January 2014 et July 2019 for CIED suspected infection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac implantable electronic device infections
Patients hospitalised in Nancy University Hospital for suspected cardiac implantable electronic device infections
Other: Diagnostic and treatment evaluation
No intervention, description of the diagnostic evaluation and the treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From January 2014 to July 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From January 2014 to July 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2019

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymous individual datas for baseline characteristcs and clinical outcomes would be available

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

Data access request will be reviewed by investigator team. Requestors will be required to signe a data access agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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