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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on severe aortic stenosis, a condition where the aortic valve narrows, limiting blood flow from the heart and causing symptoms like shortness of breath and chest pain. The study aims to assess quality of life changes in patients undergoing Transcatheter Aortic Valve Implantation (TAVI), a less invasive valve replacement method increasingly used especially in older adults. This condition is common and worsening with aging populations, and there is currently no medical treatment to slow its progression. Participants in this observational study will undergo TAVI, where a new valve is inserted via blood vessels without open-chest surgery. Quality of life will be evaluated using questionnaires, including the EQ-5D-5L and Kansas City Cardiomyopathy Questionnaire (KCCQ-12), administered at the time of the procedure and two months afterward. Patients will be grouped based on a CAPRI score calculated from pre-TAVI assessments, reflecting prognosis severity. Throughout the 12-month participation, researchers will monitor quality of life changes, focusing on KCCQ-12 score variations between baseline and two months post-TAVI. Data collected also include clinical assessments and questionnaire responses to evaluate patient wellbeing over time. Safety and procedure adherence will be observed, and the final analysis will help understand quality of life outcomes in patients with poor prognosis aortic stenosis after TAVI.
CONDITIONS
Brief 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 (valve area ≤ 1 cm² or ≤ 1 cm²/m² body surface area or mean transvalvular gradient > 40 mmHg)
- Charlson score ≥ 5
- Affiliated with social health care insurance
You will not qualify if you...
- Patient refusing the TAVI procedure
- CT scan not performed during pre-TAVI assessment
- Unable to understand or answer quality-of-life questionnaires
- Pregnant or breastfeeding women
- Participating in other interventional research that may interfere with this study
- Under judicial protection
- Under guardianship, curatorship, or safeguard of justice
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of the TAVI procedure
Participants undergo pre-TAVI assessment including CT scan and quality-of-life questionnaires to evaluate their health status before the procedure.
1 visit (in-person)
Duration - 12 months
Participants complete quality-of-life questionnaires at 2 months and are followed up until 12 months to assess changes in health status and prognosis.
1 visit at 2 months post-TAVI and additional follow-up assessments up to 12 months
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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