Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI
Key facts
- Who runs it
- Hospices Civils de Lyon
- Where
- Lyon, FranceSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 125 people, planned
- Started
- 19 Dec 2024
- Expected to end
- Jun 2030
- Type of study
- Observational, 3 groups
- Treatments tested
- Biocollection
- Quality of life questionnaires
- Record updated
- 27 May 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Patients >=18 years of age
- Patient with symptomatic or asymptomatic severe or moderately severe aortic stenosis (according to the recommendations of the European Society of Cardiology - ESC)
- No opposition
Who cannot take part
- Conjunctive heart disease (e.g. amyloidosis)
- Presence of a contraindication to TAVI
- Impossibility of giving the subject informed information
- Privation of civil rights (curatorship, tutorship, protection of justice)
Where in France
- Hospices Civils de Lyon - Hôpital Croix RousseLyon, FranceContact: Brahim Harbaoui, ProfTaking people
- Hospices Civils de Lyon - Hopital Louis PradelLyon, FranceContact: Ahmad HAYEK, MDTaking people
About the trial
What the trial wants to find out
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.
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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.
The 3 groups in the trial
- Group A
Patients with symptomatic severe aortic stenosis, with indication for TAVI. They are followed at inclusion, during hospitalisation of the TAVI procedure, at 1-month follow-up, at 1-year follow-up and by phone at 2 years follow-up.
Treatment: Biocollection and Quality of life questionnaires
- Group B
Patients with asymptomatic severe aortic stenosis, without indication for TAVI. They are followed at inclusion, at 1-month follow-up, at 1-year follow-up and at 2 years follow-up.
Treatment: Biocollection and Quality of life questionnaires
- Group C
Patients with asymptomatic middle aortic stenosis, without indication for TAVI. They are followed at inclusion, at 1-month follow-up, at 1-year follow-up and at 2 years follow-up.
Treatment: Biocollection and Quality of life questionnaires
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 27 May 2026