Identifying biomarkers for cardiovascular events in aortic stenosis patients
Official title: Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI
Run by Hospices Civils de Lyon · NCT06713889 · Data updated 2026-11-12
This study is trying to find biological markers that can help identify aortic stenosis patients at risk for heart problems, especially those getting a new heart valve, so they can get treatment sooner.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 125 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Lyon and 1 other locations) |
| Status | Recruiting |
| Started | December 19, 2024 |
| Main results expected | June 2029 |
| Study ends | June 2030 |
| Registry record updated | May 27, 2026 |
| Trial ID | NCT06713889 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with symptomatic or asymptomatic severe or moderately severe aortic stenosis.
✕Probably not a fit
Patients with contraindications to TAVI or those with other significant heart diseases like amyloidosis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to identify biological markers associated with cardiovascular events in patients suffering from aortic stenosis, particularly those undergoing Transcatheter Aortic Valve Implantation (TAVI). By assessing inflammatory and fibrosis factors through biomarkers, the study seeks to pinpoint asymptomatic patients at higher risk for earlier intervention. Patients will be recruited during their TAVI assessment consultations, and data will be collected from routine care procedures along with a biocollection of serum and plasma samples. Quality of life questionnaires will also be administered to gather comprehensive patient information.
Why it matters
Potential benefit: If successful, this study could enable earlier interventions for high-risk aortic stenosis patients, potentially improving their outcomes.
How similar studies have gone: Other studies have explored biomarkers in cardiovascular diseases, suggesting potential for success in this approach, though this specific focus on aortic stenosis is less common.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 it's running
-
Hospices Civils de Lyon - Hôpital Croix Rousse
Lyon, France Recruiting -
Hospices Civils de Lyon - Hôpital Louis Pradel
Lyon, France Recruiting
Study contacts
- Principal investigator: Ahmad HAYEK, MD — Plateau technique interventionnel - Hôpital Louis Pradel, GHE
- Study coordinator: Ahmad HAYEK, MD
- Email: ahmad.hayek@chu-lyon.fr
- Phone: 4 72 35 72 80
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Exercise and nutrition support before and after TAVI for older adults with aortic stenosis
This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.
-
Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI
This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.
-
Systematic 14-day ambulatory heart monitoring after TAVI
After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.
-
Echo-AVCS: Drawing AI-powered clues from heart scans to confirm severe aortic stenosis
This study tests an AI-based echocardiography score to help confirm severe aortic stenosis in adults who are also getting CT calcium scoring.
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TAVI without on-site heart surgery: can selected centers do it safely?
This trial tests whether transcatheter aortic valve implantation can be done safely in certain hospitals that don’t have on-site cardiac surgery, for patients with severe aortic stenosis who are appropriately selected.
-
Willem AI for early detection of aortic stenosis from a 12‑lead ECG
This project will test whether the Willem AI can detect aortic stenosis from routine 12‑lead ECGs in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.