Aortic Valve DiseaseEntero-TAVINCT04909424
Prevalence of Cutaneous Enterococci at Femoral Insertion Site in Transcatheter Aortic Valve Implantation (TAVI)
An observational study of Aortic Valve Disease, run by Clinique Pasteur at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2021to 23 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In hospital patients for pre TAVI assessment at Clinique Pasteur
Who may be able to join
- 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
Who cannot join
- TAVI procedure by non-trans femoral approach
- Protected patients: Adults under guardianship or other legal protection; Pregnant or breastfeeding woman; Hospitalized without consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Aortic Valve Disease
- Keywords
- Enterococci, Infective endocarditis, Antibiotic prophylaxis, TAVI
- Medical subject headings
- Aortic Valve Disease, Endocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
Enterococci prevalence
Proportion of patients with Enterococcus feacalis and other Enterococci in inguinal flora before TAVI
Measured: At Day 0 at TAVI intervention time (preoperative)
Secondary outcomes (3)
Skin flora of the groin
Bacteria profile of inguinal skin
Measured: At Day 0 at TAVI intervention time (preoperative) before skin disinfection
Skin flora of the groin
Bacteria profile of inguinal skin
Measured: At Day 0 at TAVI intervention time (preoperative) after skin disinfection
Infectious events
Occurrence of infective endocarditis or other infectious adverse events
Measured: From day of TAVI to 1 year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start17 Jun 2021
- Primary completion21 Feb 2022
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Pasteur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Bonnet, MD, Study chair, Clinique PasteurNicolas Combes, MD, Study chair, Clinique PasteurBenoit Fontenel, MD, Study chair, Clinique Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909424
- Sponsor's protocol ID
- 2021-A00370-41
- Acronym
- Entero-TAVI
- Status last verified
- Mar 2024
- First submitted
- 28 May 2021
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cutaneous Enterococci at Femoral Insertion Site in Transcatheter Aortic Valve Implantation (TAVI)
- ClinicalTrials.gov ID
- NCT04909424
- Acronym / sponsor ID
- Entero-TAVI / 2021-A00370-41
- Conditions
- Aortic Valve Disease
- Keywords
- Enterococci, Infective endocarditis, Antibiotic prophylaxis, TAVI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Clinique PasteurUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In hospital patients for pre TAVI assessment at Clinique Pasteur
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- TAVI procedure by non-trans femoral approach
- Protected patients: Adults under guardianship or other legal protection; Pregnant or breastfeeding woman; Hospitalized without consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Enterococci prevalence
Time frame: At Day 0 at TAVI intervention time (preoperative)
Proportion of patients with Enterococcus feacalis and other Enterococci in inguinal flora before TAVI
3 secondary outcomes
Skin flora of the groin
Time frame: At Day 0 at TAVI intervention time (preoperative) before skin disinfection
Skin flora of the groin
Time frame: At Day 0 at TAVI intervention time (preoperative) after skin disinfection
Infectious events
Time frame: From day of TAVI to 1 year after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Bonnet, MD study chair
Clinique Pasteur
Nicolas Combes, MD study chair
Clinique Pasteur
Benoit Fontenel, MD study chair
Clinique Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease, run by Clinique Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enterococci prevalence (time frame: At Day 0 at TAVI intervention time (preoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.