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

NCT07075601 | Not Yet Recruiting

• 2 other identifiers: RC31/25/00202025-A00422-47
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Valvulopathy; Cardiac Surgery; Microbiota

Outcome Measures

Primary Outcomes (1)

• Occurrence of a serious postoperative complication

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

  48 months

Secondary Outcomes (7)

• Determine the microbiological composition of saliva

  48 months

• Determine the components of the microbiota of periodontal plaque

  48 months

• Oral health assessment

  48 months

• Evaluation of hygiene and dietary habits

  48 months

• Determine the inflammatory composition of saliva

  48 months

Study Arms (1)

Patients with an indication for cardiac surgery

EXPERIMENTAL

Patients with an indication for cardiac surgery during which the aortic valve is explanted.

Biological: Take 1 ml of blood; Biological: DNA sequencing; Procedure: Valve collection (healthcare waste); Other: Collection of serious post-operative complications

Interventions

Take 1 ml of blood BIOLOGICAL

Take 1 ml of blood

Patients with an indication for cardiac surgery

DNA sequencing BIOLOGICAL

DNA sequencing

Patients with an indication for cardiac surgery

Valve collection (healthcare waste) PROCEDURE

Valve collection (healthcare waste)

Patients with an indication for cardiac surgery

Collection of serious post-operative complications OTHER

Collection of serious post-operative complications

Patients with an indication for cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Rangueil Hospital

Toulouse, France, 31 000, France

Location

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Blood Specimen Collection; Sequence Analysis, DNA

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Sequence Analysis; Genetic Techniques

Central Study Contacts

Bertrand MARCHEIX, MD

CONTACT

5 61 32 37 18; marcheix.b@chu-toulouse.fr

Audrey TOMASIK

CONTACT

5 61 77 85 97; tomasik.a@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)