Aortic StenosisBio-TAVINCT06713889
Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI
An observational study of Aortic Stenosis, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Biocollection and Quality of life questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 125 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Dec 2024to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 125 patients will be selected from among those seen in consultation for aortic stenosis assessment in the cardiology departments of the Louis Pradel and Croix-Rousse hospitals.
Who may be able to join
- 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 join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hospices Civils de Lyon - Hôpital Croix Rousse
Lyon, 69004
Brahim Harbaoui, Prof, 04 72 35 58 25 ext. +33, brahim.harbaoui@chu-lyon.fr
Brahim Harbaoui, Prof
- Recruiting
Hospices Civils de Lyon - Hôpital Louis Pradel
Lyon, 69500
Ahmad HAYEK, MD, 04 72 35 72 80 ext. +33, ahmad.hayek@chu-lyon.fr
Ahmad HAYEK, MD
About this study
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).
Read more
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
- Aortic Stenosis
- Being tested
- Biocollection, Quality of life questionnaires
- Keywords
- Aortic stenosis, TAVI, Cardiology, Biomarkers
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiocollectionBiological
At each sampling time, 2 dry tubes of 4 ml, 1 EDTA tube of 4 ml, and 1 heparinised tube of 4 ml, i.e. a total of 16 ml per sampling time.
Group A patients will be sampled at inclusion (or before the TAVI procedure), during and after the TAVI procedure, at 1 month follow-up and at 1 year follow-up, for a total of 120 ml. Patients in groups B and C will be sampled at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up, for a total of 80 ml.
Quality of life questionnairesBehavioural
EQ-5D-5L and HAD questionnaire at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Biocollection; Behavioral: 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. Receives: Biological: Biocollection; Behavioral: 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. Receives: Biological: Biocollection; Behavioral: Quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing biomarkers
The primary endpoint is the level of biomarkers of inflammation and fibrosis in the 3 groups of patients.
Measured: At V0 (inclusion), V4 (1-month follow up) and V5 (1-year follow up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start19 Dec 2024
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmad HAYEK, MD, Principal investigator, Plateau technique interventionnel - Hôpital Louis Pradel, GHE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713889
- Sponsor's protocol ID
- 69HCL21_1209
- Other IDs
- 2024-A01552-45
- Acronym
- Bio-TAVI
- Status last verified
- May 2026
- First submitted
- 27 Nov 2024
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI
- ClinicalTrials.gov ID
- NCT06713889
- Acronym / sponsor ID
- Bio-TAVI / 69HCL21_1209
- Conditions
- Aortic Stenosis
- Keywords
- Aortic stenosis, TAVI, Cardiology, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Biological: Biocollection, Behavioral: Quality of life questionnairesPatients 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. |
| Group B | – | Biological: Biocollection, Behavioral: Quality of life questionnairesPatients 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. |
| Group C | – | Biological: Biocollection, Behavioral: Quality of life questionnairesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 125 patients will be selected from among those seen in consultation for aortic stenosis assessment in the cardiology departments of the Louis Pradel and Croix-Rousse hospitals.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiocollectionAt each sampling time, 2 dry tubes of 4 ml, 1 EDTA tube of 4 ml, and 1 heparinised tube of 4 ml, i.e. a total of 16 ml per sampling time. Group A patients will be sampled at inclusion (or before the TAVI procedure), during and after the TAVI procedure, at 1 month follow-up and at 1 year follow-up, for a total of 120 ml. Patients in groups B and C will be sampled at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up, for a total of 80 ml. | Biological | Group A, Group B, Group C |
| Quality of life questionnairesEQ-5D-5L and HAD questionnaire at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up | Behavioural | Group A, Group B, Group C |
Primary outcome
Comparing biomarkers
Time frame: At V0 (inclusion), V4 (1-month follow up) and V5 (1-year follow up).
The primary endpoint is the level of biomarkers of inflammation and fibrosis in the 3 groups of patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmad HAYEK, MD principal investigator
Plateau technique interventionnel - Hôpital Louis Pradel, GHE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmad HAYEK, MD (4 72 35 72 80 ext. +33, ahmad.hayek@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing biomarkers (time frame: At V0 (inclusion), V4 (1-month follow up) and V5 (1-year follow up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.