Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06407128

Valvular Microbiota and Valvulopathy

Led by University Hospital, Toulouse · Updated on 2024-05-09

100

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Valvular Microbiota and Valvulopathy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Indication for surgical aortic valve replacement (AVR) including:
    • Severe aortic stenosis with symptoms such as dyspnea, syncope/lipothymia, or angina
    • Echocardiographic criteria: valve surface less than 1 cm² or 0.6 cm²/m², average transvalvular gradient over 40 mmHg, aortic jet velocity over 4.0 m/s
    • Low transvalvular gradient with LVEF under 50% but with contractile reserve
    • High calcium score on CT angiography
    • Asymptomatic severe aortic stenosis with LVEF under 50% without other cause
    • Symptoms during exercise
    • Low surgical risk plus severity criteria such as Vmax over 5.5 m/s, NT-proBNP levels over 3 times normal, or severe pulmonary arterial hypertension
    • Moderate aortic regurgitation with surgical indication for another heart disease
    • Severe aortic insufficiency with regurgitant orifice over 30 mm² or regurgitated volume over 60 ml/beat, with symptoms or left ventricular dysfunction
  • Concomitant surgical indication for another heart disease
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University Hospital

Toulouse, France, 31059

Actively Recruiting

Loading map...

Research Team

J

Jean PORTERIE, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here