Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT04501835
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2020-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Diagnostic and Therapeutic Practices for Cardiac Implantable Electronic Devices Suspected Infections in Nancy University Hospital
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Assessment of Diagnostic and Therapeutic Practices for Cardiac Implantable Electronic Devices Suspected Infections in Nancy University Hospital
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: