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NCT Number: NCT07075601

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Take 1 ml of blood

Biological

Take 1 ml of blood

DNA sequencing

Biological

DNA sequencing

Valve collection (healthcare waste)

Procedure

Valve collection (healthcare waste)

Collection of serious post-operative complications

Other

Collection of serious post-operative complications

Primary outcomes

  1. Occurrence of a serious postoperative complication

    Time frame: 48 months

    Number of ischemic or hemorrhagic strokes; re-intervention, infective endocarditis, aortic bioprosthesis degeneration, aortic bioprosthesis thrombosis, mortality, surgical site infection requiring repeat surgery

Secondary outcomes

  1. Determine the microbiological composition of saliva

    Time frame: 48 months

    Determine the components of the salivary microbiota

  2. Determine the components of the microbiota of periodontal plaque

    Time frame: 48 months

    Determine the components of the microbiota of periodontal plaque

  3. Oral health assessment

    Time frame: 48 months

    Oral 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.

  4. Evaluation of hygiene and dietary habits

    Time frame: 48 months

    Assessment 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

  5. Determine the inflammatory composition of saliva

    Time frame: 48 months

    Determining inflammatory molecules in saliva

  6. Determine the immune composition of saliva

    Time frame: 48 months

    Determine the immune cells and molecules found in saliva

  7. Determine the microbiological composition of feces

    Time frame: 48 months

    Determine the molecules that make up the fecal microbiota

Study contacts

Contact information is provided by the study sponsor or research team.

Audrey TOMASIK

CONTACT

[email protected]

5 61 77 85 97 ext. +33

Bertrand MARCHEIX, MD

CONTACT

[email protected]

5 61 32 37 18 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: BIOVALV

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 20, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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