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CompletedNCT06407128MICROVALVUpdated May 29, 2026

Valvular Microbiota and Valvulopathy

An interventional study of Collection of biological samples in Valvulopathy, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2024, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

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Conditions studied

  • Valvulopathy

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Keywords

  • Microbiota
03

In context

Heart Valve Diseases

535 studies on the registry are indexed under Heart Valve Diseases; 173 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 291 interventional studies indexed under Heart Valve Diseases.

Browse Heart Valve Diseases studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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;
  • 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.
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Collection of biological samples

    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.

    Biological: Collection of biological samples

Interventions

  • BiologicalCollection of biological samples

    Collection of biological samples (blood sample + valve tissue sample + saliva, periodontal and feces sample)

06

What researchers measure

Primary outcomes

  1. Detection of blood and tissue microbiota

    Detection of a blood microbiota in the pre-operative sample and a valve microbiota in the operating part.

    Time frame: 12 months

07

Study locations

1 site
  • University Hospital
    Toulouse, 31059, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06407128
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
May 9, 2024
Start date
Jan 9, 2024
Primary completion
Aug 30, 2025
Completion
Aug 30, 2025
Last update
May 29, 2026

Study contacts

Jean PORTERIE, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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