Act on Quality of Life in Poor Prognosis Aortic Stenosis Patients

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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number of TAVIs equalled the number of surgeries by 2015, and TAVIs currently account for ¾ of aortic valve procedures (unpublished data).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Service de Cardiologie - CHU Clermont Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
Service de Cardiologie
NOT_YET_RECRUITING
Lille
Service de Cardiologie
RECRUITING
Lyon
Service de Cardiologie - Institut Thorax Nantes
NOT_YET_RECRUITING
Nantes
Contact Information
Primary
Pierre Lantelme, MD
pierre.lantelme@chu-lyon.fr
04.72.07.25.36
Backup
Julia Canterini
Julia.canterini@chu-lyon.fr
04 27 85 66 28
Time Frame
Start Date: 2024-12-19
Estimated Completion Date: 2027-12-19
Participants
Target number of participants: 240
Treatments
Poor prognosis patients
Patients will performed the Quality Of Life Questionnaire (EQ-5D-5L) and the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) at baseline (day of the TAVI procedure) and 2 months post-TAVI. The CAPRI score will be calculated from the data of the pre TAVI assessment at the end of study participation (12 months) and will determine the group of the patient. The higher the score, the worse the prognosis.
Intermediate prognosis patients
Patients will performed the Quality Of Life Questionnaire (EQ-5D-5L) and the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) at baseline (day of the TAVI procedure) and 2 months post-TAVI. The CAPRI score will be calculated from the data of the pre TAVI assessment at the end of study participation (12 months) and will determine the group of the patient. The higher the score, the worse the prognosis
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov