Actively Recruiting

Age: 18Years +
All Genders
NCT06713889

Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI

Led by Hospices Civils de Lyon · Updated on 2025-11-25

125

Participants Needed

2

Research Sites

180 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Aortic stenosis, a common cardiovascular disease, is pathophysiologically associated with a chronic inflammatory myocardial reaction and fibrosis leading to cardiac dysfunction and impaired coronary perfusion. These elements may precede the onset of symptoms. The assessment of inflammatory and fibrosis factors (in particular by means of biomarkers) in patients with aortic stenosis will make it possible to identify asymptomatic patients at greater risk who could benefit from intervention earlier. This is part of a personalised medicine adapted to the patient. Patients will be recruited during their TAVI (Transcatheter Aortic Valve Implantation) assessment consultation. If the patient agrees to take part in the study, information relating to routine care procedures will be collected (patient history, clinical examinations, electrocardiogram, echography, coronary angiography, TAVI procedure if applicable, biology). Outside of routine care, a biocollection will be established (serum, plasma), quality of life questionnaires will be carried out and adverse events will be collected where present. Patients will be divided into 3 groups according to the indication for TAVI (Group A - symptomatic severe aortic stenosis with indication for TAVI, Group B - asymptomatic severe aortic stenosis without indication for TAVI, Group C - asymptomatic moderate aortic stenosis without indication for TAVI). The main objective is to compare the levels of biomarkers of inflammation and fibrosis between the 3 groups at each sampling time common to all three groups between inclusion and 1-year follow-up.

CONDITIONS

Official Title

Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years of age or older
  • Diagnosed with symptomatic or asymptomatic severe or moderately severe aortic stenosis according to European Society of Cardiology recommendations
  • No objection to participate in the study
Not Eligible

You will not qualify if you...

  • Presence of other heart diseases such as amyloidosis
  • Contraindication to TAVI procedure
  • Unable to provide informed consent
  • Legal protection status such as curatorship, tutorship, or judicial protection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hospices Civils de Lyon - Hôpital Croix Rousse

Lyon, France, 69004

Actively Recruiting

2

Hospices Civils de Lyon - Hôpital Louis Pradel

Lyon, France, 69500

Actively Recruiting

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Research Team

A

Ahmad HAYEK, MD

CONTACT

Y

Yvonne VARILLON

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI | DecenTrialz