Actively Recruiting
Act on Quality of Life in Patients With aortIc Stenosis
Led by Hospices Civils de Lyon · Updated on 2025-01-17
240
Participants Needed
4
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Aortic stenosis (AS) is a degenerative process affecting the aortic valve that leads to sclerosis of the valve and limits its opening during cardiac contractions. The prognosis is poorly, with survival rates of only 15-50% at 5 years. AS has a major impact on quality of life, with severely limiting symptoms (dyspnea, chest pain,…) often leading to repeated hospitalizations. It is the most common valvular disease in Europe and North America, and its prevalence is increasing as the population ages. In Europe, 17% of the population is aged 65 or over; in France, this proportion will reach 30% by 2030, corresponding to 16 million people. The incidence of aortic valve sclerosis (early stage AS) is around 25% at age 65, rising to 48% after age 75. The prevalence of aortic valve disease is likely to continue to rise, given the expected evolution of the age pyramid. There is no medical treatment able to slow down the degenerative process of the valve, and the only treatment is aortic valve replacement when the AS becomes constricted and the patient is eligible for an intervention. Aortic valve replacement has historically been performed surgically, with open-chest surgery to remove the damaged valve and replace it with a mechanical or biological valve prosthesis. Now Transcatheter Aortic Valve Implantation (TAVI) has replaced this procedure. This involves inserting a bioprosthesis crimped into a stent via an endovascular route, i.e. without opening the thorax. Deployment of the stent crushes the native valve, leaving the functional bioprosthesis in place. Initially developed for patients contraindicated to surgery, TAVI is now offered as a first-line treatment for patients aged 75 and over. Inexistent before 2010, the number of TAVIs equalled the number of surgeries by 2015, and TAVIs currently account for ¾ of aortic valve procedures (unpublished data).
CONDITIONS
Official Title
Act on Quality of Life in Patients With aortIc Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with symptomatic aortic stenosis (exertional dyspnea, angina, malaise/syncope)
- Indication for TAVI validated by Heart Team with valve area 1 cm8 or 1 cm8/m8 body surface area or mean transvalvular aortic gradient > 40 mmHg on ultrasound
- Charlson score 65
- Affiliation with social health care insurance
You will not qualify if you...
- Patient refusing TAVI procedure
- CT scan not performed during the pre-TAVI assessment
- Patient unable to understand or answer quality-of-life questionnaires
- Pregnant or breast-feeding women
- Patients participating in other interventional research with an exclusion period still in progress
- Persons under judicial protection
- Patients under guardianship, curators or safeguard of justice
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Service de Cardiologie - CHU Clermont Ferrand
Clermont-Ferrand, France, 63000
Not Yet Recruiting
2
Service de Cardiologie
Lille, France, 59000
Not Yet Recruiting
3
Service de Cardiologie
Lyon, France, 69004
Actively Recruiting
4
Service de Cardiologie - Institut Thorax Nantes
Nantes, France, 44000
Not Yet Recruiting
Research Team
P
Pierre Lantelme, MD
CONTACT
J
Julia Canterini
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
2
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