Ireland
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Recruiting Not applicable

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

NCT07075601 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-11-19
Last updated
2026-06-01

Condition(s) studied

ValvulopathyCardiac SurgeryMicrobiota

Investigational drug(s) / intervention(s)

Take 1 ml of bloodDNA sequencingValve collection (healthcare waste)Collection of serious post-operative complications

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • Occurrence of a serious postoperative complication — 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

Trial sites (1)

FacilityCityRegionStatus
Rangueil Hospital Toulouse France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07075601 on ClinicalTrials.gov ↗ ← All trials in France