ValvulopathyMICROVALVNCT06407128
Valvular Microbiota and Valvulopathy
A study testing Collection of biological samples in people with Valvulopathy, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Few teams in the world can reliably analyze tissue microbiota. In this regard, the present group has unique expertise in the analysis of blood and tissue microbiota, the first to describe in 2011. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvulopathy
- What is being tested?
- Collection of biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Indication for surgical AVR:
- Tight RA:
- symptomatic (dyspnea, syncope/lipothymia, angina);
- and/or echocardiographic criterion:
- valve surface < 1cm2 (and/or 0.6cm2/m2);
- average transvalvular gradient > 40mmHg;
Show all 18Show fewer
- aortic jet velocity (Vmax) > 4.0m/s;
- or low transvalvular gradient (mean gradient < 40mmHg) + left ventricular ejection fraction (LVEF) < 50% but contractile reserve;
- and/or high calcium score on CT angiography;
- Asymptomatic tight RA and:
- LVEF < 50% without other cause;
- and/or symptoms during exercise;
- and/or low surgical risk + severity criteria: Vmax > 5.5m/s (or progression > 0.3m/s/year), NT-proBNP level > 3Xnormal, severe pulmonary arterial hypertension (pulmonary systolic pressure > 60mmHg);
- Moderate AR + concomitant surgical indication for another heart disease;
- Severe AI: regurgitant orifice > 30mm2, regurgitated volume > 60ml/beat,
- symptomatic (dyspnea, syncope/lipothymia, angina);
- and/or left ventricular dysfunction: LVEF < 50%, end-diastolic diameter > 70mm, end-systolic diameter > 50mm (or > 25mm/m2);
- and/or concomitant surgical indication for another heart disease.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Few teams in the world can reliably analyze tissue microbiota. In this regard, the present group has unique expertise in the analysis of blood and tissue microbiota, the first to describe in 2011.
Having a blood biomarker of this valve microbiota could help guide the therapeutic strategy before and after the intervention. This study will be the first to test the hypothesis that the analysis of the blood microbiota makes it possible to detect the carriage of a tissue microbiota in patients undergoing aortic valve replacement (AVR) for degenerative aortic valve disease and should also lay the foundations for a prospective study. intended to evaluate the impact of the blood and valve microbiota on the post-operative prognosis of these patients and the complications at one year. This would be a first proof of concept of the role of the tissue microbiota in valvular degeneration linked to aging.
- Conditions
- Valvulopathy
- Being tested
- Collection of biological samples
- Keywords
- Microbiota
- 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.
Collection of biological samplesBiological
Collection of biological samples (blood sample + valve tissue sample + saliva, periodontal and feces sample)
| Study group | Role | What they receive |
|---|---|---|
| Collection of biological samples | Experimental | The samples (1ml blood sample + approximately 90-100mg of valve tissue + saliva, periodontal and feces samples) will be collected at the time of T0 inclusion in the cardiovascular surgery department. Receives: Biological: Collection of biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of blood and tissue microbiota
Detection of a blood microbiota in the pre-operative sample and a valve microbiota in the operating part.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start9 Jan 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean PORTERIE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407128
- Sponsor's protocol ID
- RC31/22/0108
- Acronym
- MICROVALV
- Status last verified
- May 2026
- First submitted
- 6 May 2024
- Last updated
- 29 May 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valvular Microbiota and Valvulopathy
- ClinicalTrials.gov ID
- NCT06407128
- Acronym / sponsor ID
- MICROVALV / RC31/22/0108
- Conditions
- Valvulopathy
- Keywords
- Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 9 May 2024 (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.
Few teams in the world can reliably analyze tissue microbiota. In this regard, the present group has unique expertise in the analysis of blood and tissue microbiota, the first to describe in 2011.
Having a blood biomarker of this valve microbiota could help guide the therapeutic strategy before and after the intervention. This study will be the first to test the hypothesis that the analysis of the blood microbiota makes it possible to detect the carriage of a tissue microbiota in patients undergoing aortic valve replacement (AVR) for degenerative aortic valve disease and should also lay the foundations for a prospective study. intended to evaluate the impact of the blood and valve microbiota on the post-operative prognosis of these patients and the complications at one year. This would be a first proof of concept of the role of the tissue microbiota in valvular degeneration linked to aging.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collection of biological samples | Experimental | Biological: Collection of biological samplesThe samples (1ml blood sample + approximately 90-100mg of valve tissue + saliva, periodontal and feces samples) will be collected at the time of T0 inclusion in the cardiovascular surgery department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Indication for surgical AVR:
- valve surface < 1cm2 (and/or 0.6cm2/m2);
- average transvalvular gradient > 40mmHg;
- aortic jet velocity (Vmax) > 4.0m/s;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Collection of biological samplesCollection of biological samples (blood sample + valve tissue sample + saliva, periodontal and feces sample) | Biological | Collection of biological samples |
Primary outcome
Detection of blood and tissue microbiota
Time frame: 12 months
Detection of a blood microbiota in the pre-operative sample and a valve microbiota in the operating part.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
Related trials for Valvulopathy
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Active, not recruiting
TRISCEND JAPAN Study
Tricuspid Valve Regurgitation, Heart Valve Diseases
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
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. This study is not recruiting at the moment.
Jean PORTERIE, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of biological samples in people with Valvulopathy, 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 18 inclusion and 0 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: finished, as of the sponsor's last update on 29 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of blood and tissue microbiota (time frame: 12 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 29 May 2026.