ValvulopathyBIOVALVNCT07075601
Non-interventional Study Exploring the Composition of the Valvular Microbiota of Patients Undergoing Cardiac Surgery
A study testing Take 1 ml of blood, DNA sequencing and Valve collection (healthcare waste) in people with Valvulopathy and Cardiac Surgery, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvulopathy, Cardiac Surgery, Microbiota
- What is being tested?
- Take 1 ml of blood, DNA sequencing and Valve collection (healthcare waste)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2025to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients infected with HIV
- Age under 18
- Under court supervision, guardianship, or curatorship
- Patients with a history of infective endocarditis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rangueil Hospital
Toulouse, France, 31 000
Bertrand MARCHEIX, MD, 561323718 ext. +33, marcheix.b@chu-toulouse.fr
Audrey TOMASIK, 5 61 77 85 97 ext. +33, tomasik.a@chu-toulouse.fr
About this study
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
- Being tested
- Take 1 ml of blood, DNA sequencing, Valve collection (healthcare waste), Collection of serious post-operative complications
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take 1 ml of bloodBiological
Take 1 ml of blood
DNA sequencingBiological
DNA sequencing
Valve collection (healthcare waste)Procedure or surgery
Valve collection (healthcare waste)
Collection of serious post-operative complicationsOther
Collection of serious post-operative complications
| Study group | Role | What they receive |
|---|---|---|
| Patients with an indication for cardiac surgery | Experimental | Patients with an indication for cardiac surgery during which the aortic valve is explanted. Receives: Biological: Take 1 ml of blood; Biological: DNA sequencing; Procedure: Valve collection (healthcare waste); Other: Collection of serious post-operative complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 months
Secondary outcomes (7)
Determine the microbiological composition of saliva
Determine the components of the salivary microbiota
Measured: 48 months
Determine the components of the microbiota of periodontal plaque
Determine the components of the microbiota of periodontal plaque
Measured: 48 months
Oral health assessment
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.
Measured: 48 months
Evaluation of hygiene and dietary habits
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
Measured: 48 months
Determine the inflammatory composition of saliva
Determining inflammatory molecules in saliva
Measured: 48 months
Determine the immune composition of saliva
Determine the immune cells and molecules found in saliva
Measured: 48 months
Determine the microbiological composition of feces
Determine the molecules that make up the fecal microbiota
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start19 Nov 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ValvulopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075601
- Sponsor's protocol ID
- RC31/25/0020
- Other IDs
- 2025-A00422-47
- Acronym
- BIOVALV
- Status last verified
- May 2026
- First submitted
- 10 Jul 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study Exploring the Composition of the Valvular Microbiota of Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07075601
- Acronym / sponsor ID
- BIOVALV / RC31/25/0020
- Conditions
- Valvulopathy, Cardiac Surgery, Microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with an indication for cardiac surgery | Experimental | Biological: Take 1 ml of blood, Biological: DNA sequencing, Procedure: Valve collection (healthcare waste), Other: Collection of serious post-operative complicationsPatients with an indication for cardiac surgery during which the aortic valve is explanted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients infected with HIV
- Age under 18
- Under court supervision, guardianship, or curatorship
- Patients with a history of infective endocarditis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Take 1 ml of bloodTake 1 ml of blood | Biological | Patients with an indication for cardiac surgery |
| DNA sequencingDNA sequencing | Biological | Patients with an indication for cardiac surgery |
| Valve collection (healthcare waste)Valve collection (healthcare waste) | Procedure or surgery | Patients with an indication for cardiac surgery |
| Collection of serious post-operative complicationsCollection of serious post-operative complications | Other | Patients with an indication for cardiac surgery |
Primary outcome
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
7 secondary outcomes
Determine the microbiological composition of saliva
Time frame: 48 months
Determine the components of the microbiota of periodontal plaque
Time frame: 48 months
Oral health assessment
Time frame: 48 months
Evaluation of hygiene and dietary habits
Time frame: 48 months
Determine the inflammatory composition of saliva
Time frame: 48 months
Determine the immune composition of saliva
Time frame: 48 months
Determine the microbiological composition of feces
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take 1 ml of blood, DNA sequencing and Valve collection (healthcare waste) in people with Valvulopathy and Cardiac Surgery, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bertrand MARCHEIX, MD (5 61 32 37 18 ext. +33, marcheix.b@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a serious postoperative complication (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.