Non-interventional Study Exploring the Composition of the Valvular Microbiota of Patients Undergoing Cardiac Surgery
NCT ID: NCT07075601
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-08-01
2029-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Patients with an indication for cardiac surgery
Patients with an indication for cardiac surgery during which the aortic valve is explanted.
Take 1 ml of blood
Take 1 ml of blood
DNA sequencing
DNA sequencing
Valve collection (healthcare waste)
Valve collection (healthcare waste)
Collection of serious post-operative complications
Collection of serious post-operative complications
Interventions
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Take 1 ml of blood
Take 1 ml of blood
DNA sequencing
DNA sequencing
Valve collection (healthcare waste)
Valve collection (healthcare waste)
Collection of serious post-operative complications
Collection of serious post-operative complications
Eligibility Criteria
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Inclusion Criteria
* 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
* Age under 18
* Under court supervision, guardianship, or curatorship
* Patients with a history of infective endocarditis.
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Locations
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Rangueil Hospital
Toulouse, France, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-A00422-47
Identifier Type: OTHER
Identifier Source: secondary_id
RC31/25/0020
Identifier Type: -
Identifier Source: org_study_id
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