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CompletedNCT04909424Entero-TAVIUpdated Mar 6, 2026

Prevalence of Cutaneous Enterococci at Femoral Insertion Site in Transcatheter Aortic Valve Implantation (TAVI)

An observational study in Aortic Valve Disease, sponsored by Clinique Pasteur. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by Clinique Pasteur · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

The general rules of antibiotic prophylaxis in surgery or interventional medicine include the choice of an antibiotic active on the bacteria most frequently encountered in surgical site infections. This antibiotic must cover, the bacteria present on the skin and recognized as responsible for surgical site infections.

The aim of this study is to identify bacteria found in skin flora in the inguinal region of patients undergoing Transcatheter Aortic Valve Implantation (TAVI). Flora found will allow to evaluate the impact of skin preparation and antibiotic prophylaxis protocols as they are currently practiced.

02

Conditions studied

  • Aortic Valve Disease

Keywords

  • Enterococci
  • Infective endocarditis
  • Antibiotic prophylaxis
  • TAVI
03

In context

Aortic Valve Disease

234 studies on the registry are indexed under Aortic Valve Disease; 70 are open to participants now.

This study's enrollment of 100 is below the median of 200 across 106 observational studies indexed under Aortic Valve Disease.

Browse Aortic Valve Disease studies →

Lead sponsor

Clinique Pasteur is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

In hospital patients for pre TAVI assessment at Clinique Pasteur

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient scheduled for aortic valve replacement by TAVI procedure with trans femoral approach
  • Patient with pre-TAVI assessment performed at Clinique Pasteur
  • Patient affiliated or beneficiary of a social security scheme
  • Patient accepting to participate and having given his no objection

Exclusion criteria

Exclusion Criteria:

  • TAVI procedure by non-trans femoral approach
  • Protected patients: Adults under guardianship or other legal protection; Pregnant or breastfeeding woman; Hospitalized without consent.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Enterococci prevalence

    Proportion of patients with Enterococcus feacalis and other Enterococci in inguinal flora before TAVI

    Time frame: At Day 0 at TAVI intervention time (preoperative)

Secondary outcomes

  1. Skin flora of the groin

    Bacteria profile of inguinal skin

    Time frame: At Day 0 at TAVI intervention time (preoperative) before skin disinfection

  2. Skin flora of the groin

    Bacteria profile of inguinal skin

    Time frame: At Day 0 at TAVI intervention time (preoperative) after skin disinfection

  3. Infectious events

    Occurrence of infective endocarditis or other infectious adverse events

    Time frame: From day of TAVI to 1 year after intervention

07

Study locations

1 site
  • Clinique Pasteur
    Toulouse, 31076, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2021 to primary completion in Feb 2022, 8 months.

Of 47 non-industry observational studies under Aortic Valve Disease, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 147. This study's 8 months is below that.

Counting every sponsor, half of 56 studies reached it within 49 months; a quarter within 23 and three quarters within 97.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2021
First posted
Jun 1, 2021
StartActual
Jun 17, 2021
Primary completionActual
Feb 21, 2022
CompletionActual
Nov 23, 2023
Last update
Mar 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04909424
Lead sponsor
Clinique Pasteur
Responsible party
Sponsor
First posted
Jun 1, 2021
Start date
Jun 17, 2021
Primary completion
Feb 21, 2022
Completion
Nov 23, 2023
Last update
Mar 6, 2026

Study contacts

Eric Bonnet, MD
study chair · Clinique Pasteur
Nicolas Combes, MD
study chair · Clinique Pasteur
Benoit Fontenel, MD
study chair · Clinique Pasteur

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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