Actively Recruiting
Act on Quality of Life in Poor Prognosis Aortic Stenosis Patients
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 condition where the aortic valve becomes stiff and narrows, limiting its opening during heartbeats. This leads to severe symptoms like shortness of breath, chest pain, and fainting, which greatly impact quality of life and often cause repeated hospital stays. AS is the most common valve disease in Europe and North America, especially affecting older adults, with its prevalence rising due to an aging population. Currently, there is no medical treatment to slow valve degeneration, and survival rates are low over five years. The main treatment for severe AS is aortic valve replacement. Traditionally, this was done through open-chest surgery, but now Transcatheter Aortic Valve Implantation (TAVI) is commonly used. TAVI involves inserting a new valve via blood vessels without opening the chest, crushing the damaged valve and placing a functional bioprosthesis. Initially for patients who could not undergo surgery, TAVI is now offered as the first choice for patients aged 75 and older. This study evaluates changes in quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score from the time of inclusion to two months later. Participants will be patients with symptomatic severe aortic stenosis eligible for TAVI, assessed by clinical and ultrasound criteria. Researchers will measure changes in quality of life over two months after inclusion using the KCCQ-12 questionnaire. Patients must have health insurance and meet other medical criteria to participate. The study excludes those refusing TAVI, unable to complete questionnaires, pregnant or breastfeeding women, and those involved in conflicting research or under legal protection. This trial helps understand quality of life impacts for patients undergoing TAVI treatment.
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
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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
J
Julia Canterini
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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