Improving quality of life for patients with severe aortic stenosis
Act on Quality of Life in Poor Prognosis Aortic Stenosis Patients
This study looks at how severe aortic stenosis affects the daily lives of patients to see if a new heart valve procedure can help improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 4 sites (Clermont-Ferrand and 3 other locations) |
| Trial ID | NCT06477042 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with severe aortic stenosis, a condition that significantly impacts quality of life due to symptoms like dyspnea and chest pain. It aims to assess the quality of life in these patients using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score. The study includes patients who are symptomatic and have an indication for transcatheter aortic valve implantation (TAVI). The research is crucial as it addresses a growing health concern among the aging population, particularly in Europe and North America.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with symptomatic severe aortic stenosis who are indicated for TAVI.
Not a fit: Patients who refuse the TAVI procedure or are unable to complete quality-of-life questionnaires may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies that enhance the quality of life for patients suffering from severe aortic stenosis.
How similar studies have performed: Other studies have shown success in assessing quality of life in patients with aortic stenosis, making this approach both relevant and supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with symptomatic aortic stenosis (exertional dyspnea, angina, malaise/syncope) * Indication for TAVI (valve area 1 cm² or 1 cm²/m² body surface area or mean transvalvular aortic gradient \> 40 mmHg on ultrasound) validated in Heart Team * Charlson score ≥ 5 * Social health care insurance affiliation Exclusion Criteria: * 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 that may interfere with the present study with an exclusion period still in progress * Persons under judicial protection * Patients under guardianship, curators or safeguard of justice
Where this trial is running
Clermont-Ferrand and 3 other locations
- Service de Cardiologie - CHU Clermont Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
- Service de Cardiologie — Lille, France (Not_yet_recruiting)
- Service de Cardiologie — Lyon, France (Recruiting)
- Service de Cardiologie - Institut Thorax Nantes — Nantes, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Pierre Lantelme, MD
- Email: pierre.lantelme@chu-lyon.fr
- Phone: 04.72.07.25.36
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.