Valvular Microbiota and Valvulopathy

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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Key information

Conditions

Valvulopathy Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collection of biological samples

Biological

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: MICROVALV

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: May 9, 2024
Registry last updated: May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed