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Non-interventional Study Exploring the Composition of the Valvular Microbiota of Patients Undergoing Cardiac Surgery

Non-interventional Study Exploring the Composition of the Valvular Microbiota of Patients Undergoing Cardiac Surgery

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07075601
Acronym
BIOVALV
Enrollment
200
Registered
2025-07-20
Start date
2025-08-01
Completion date
2029-08-31
Last updated
2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvulopathy, Cardiac Surgery, Microbiota

Brief summary

The prevalence of aortic valve disease is increasing, with these valvulopathies present in half of individuals over the age of 65. Oberbach A. et al (1) demonstrated the presence of microbiota in 52% of cases of explanted aortic valves. One current hypothesis is the role of this microbiota in the pathophysiology of these degenerative valve diseases. This microbiota is probably not completely eradicated after resection of the native valve and implantation of a conventional prosthesis; it is even left in place during percutaneous aortic valve implantation, during which the prosthesis is deployed within the native valve. It could therefore also play a role in the occurrence of postoperative complications and the degeneration or thrombosis of a bioprosthesis. Furthermore, recent clinical and epidemiological studies have shown a link between oral infections and cardiovascular diseases. As recommended by the HAS, these patients require multidisciplinary care, involving cardiologists, cardiac surgeons and general practitioners, as well as careful oral and dental care and monitoring provided by specialists in oral pathologies and oral care. The accumulation of bacterial plaque on the surface of the tooth and certain oral bacteria causes the development of periodontal pockets which are characteristic of periodontitis. Bacteria, microbial products and inflammatory mediators produced locally can then enter the bloodstream and affect distant organs such as the cardiovascular system. The recommendations of the European Society of Cardiology are therefore to carry out regular oral and dental consultations to prevent the risk of infection. Therefore, within the Toulouse University Hospital, a care network has been set up for patients with cardiovascular pathologies, in order to improve their access to dental care, screening and management of oral diseases. For the past year, patients hospitalized in the cardiology departments have been seen in consultation in the dental department of the Toulouse University Hospital.

Interventions

BIOLOGICALTake 1 ml of blood

Take 1 ml of blood

BIOLOGICALDNA sequencing

DNA sequencing

PROCEDUREValve collection (healthcare waste)

Valve collection (healthcare waste)

OTHERCollection of serious post-operative complications

Collection of serious post-operative complications

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male or female patient. * Present an indication for cardiac surgery that requires explantation of the aortic valve. * Be able to receive information about the study process and understand the study participation information form. * State their non-opposition to participating in the study.

Exclusion criteria

* Patients infected with HIV * Age under 18 * Under court supervision, guardianship, or curatorship * Patients with a history of infective endocarditis.

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of a serious postoperative complication48 monthsNumber of ischemic or hemorrhagic strokes; re-intervention, infective endocarditis, aortic bioprosthesis degeneration, aortic bioprosthesis thrombosis, mortality, surgical site infection requiring repeat surgery

Secondary

MeasureTime frameDescription
Determine the components of the microbiota of periodontal plaque48 monthsDetermine the components of the microbiota of periodontal plaque
Oral health assessment48 monthsOral health assessment using the oral health assessment questionnaire called Oral Study which asks questions about the use of a toothbrush, interdental brushes, the frequency of visits to the dentist, and the use of mouthwash.
Evaluation of hygiene and dietary habits48 monthsAssessment of dietary habits using a questionnaire on eating habits and the frequency of consumption of certain foods (bread, rusks, rice, pasta, vegetables, fruits, dairy products, fish, meat) with multiple choices between: Several times a day - Once a day - Several times a week - Once or twice a month - Never
Determine the microbiological composition of saliva48 monthsDetermine the components of the salivary microbiota
Determine the immune composition of saliva48 monthsDetermine the immune cells and molecules found in saliva
Determine the microbiological composition of feces48 monthsDetermine the molecules that make up the fecal microbiota
Determine the inflammatory composition of saliva48 monthsDetermining inflammatory molecules in saliva

Countries

France

Contacts

Primary ContactBertrand MARCHEIX, MD
marcheix.b@chu-toulouse.fr5 61 32 37 18
Backup ContactAudrey TOMASIK
tomasik.a@chu-toulouse.fr5 61 77 85 97

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026