NCT02251262: ENDOTEP

Diagnostic Accuracy of 18FDG-PET-CT for Pacing or Defibrillation Lead Infection

Completed NA Last updated 9 February 2022

What this trial tests

NA trial testing Whole-body 18FDG-PET-CT scan in Infections of the Implanted Material in 235 participants. Completed in 19 June 2018.

Timeline

22 June 2015

Primary endpoint
19 June 2018

19 June 2018

Quick facts

Lead sponsor	University Hospital, Bordeaux
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	single
Primary purpose	diagnostic
Enrollment	235
Start date	22 June 2015
Primary completion	19 June 2018
Estimated completion	19 June 2018
Sites	6 locations across France

Drugs / interventions tested

• Whole-body 18FDG-PET-CT scan

Conditions studied

• Infections of the Implanted Material — all drugs for Infections of the Implanted Material →
• Endocarditis — all drugs for Endocarditis →

Sponsor

University Hospital, Bordeaux

Who can join

18 and older, any sex, with Infections of the Implanted Material or Endocarditis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

With aging of the general population and broadening indications, the number of pacemaker recipients is steadily increasing. The incidence of infections of the implanted material, a dreaded major complication, is also rising. The diagnosis is evident in presence of an abscessed pocket, cutaneous breakthrough of the pulse generator or vegetations attached to the lead. On the other hand, a proportion of patients present with less specific clinical manifestations and a pacemaker recipient may be recurrently hospitalized for an infectious disorder of unknown origin despite detailed investigations. Without proof of lead infection, removal of the system without confirmation of its infection is usually proposed, despite the known morbidity and mortality associated with the extraction procedure (0.5 to 2%). Positive culture of the leads implies that the leads were involved in the infectious process. In recent years, 18FDG-PET-CT scan has made promising contributions in different areas including imaging to detect infection at different organ sites. Absence of hyperfixation of the lead, identified by 18FDG-PET/CT scan may be an accurate sign of absence of pacing system infection.

The extraction of intracardiac implanted material, when it is indicated by the current standard strategy, may result in negative bacteriological cultures in 10 to 25% of patients, even when they did not receive antibiotics before extraction.

The hypothesis of the study is that a new strategy adding 18FDG-PET-CT to the current strategy may avoid or reduce these false-positives.

Therefore it is hypothesized that the sensitivity of 18FDG-PET-CT will be high enough to avoid unnecessary extractions of uninfected leads, resulting in a high negative predictive value of the new diagnostic strategy incorporating 18FDG-PET-CT. The present study aims at providing valid estimates of diagnostic accuracy parameters of 18FDG-PET-CT, especially its sensitivity.

For this clinical study, firstly, 18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit; secondarily, an intervention for the extraction of the intra-cardiac material, under general anesthesia, will be practiced and then a bacteriological culture for extracted material will be required.

The end of study visit is complete the last day of material extraction. The follow up will last 2 to 7 days.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Accuracy of Positron Emission Tomography as a Diagnostic Tool for Lead Endocarditis: Design of the Prospective Multicentre ENDOTEP Study.
   Amraoui S, Tlili G, Hindié E, Perez P, et al · · 2016 · cited 2× · PMID 30310444 · DOI 10.15420/ecr.2016:6:2