Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-01-09
2026-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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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.
Collection of biological samples
Collection of biological samples (blood sample + valve tissue sample + saliva, periodontal and feces sample)
Interventions
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Collection of biological samples
Collection of biological samples (blood sample + valve tissue sample + saliva, periodontal and feces sample)
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Jean PORTERIE, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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University Hospital
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC31/22/0108
Identifier Type: -
Identifier Source: org_study_id
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