Clinical trial NCT06477042: Act on Quality of Life in Patients With aortIc Stenosis
Official title: Act on Quality of Life in Poor Prognosis Aortic Stenosis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Aortic Stenosis
Keywords: TAVI
quality of life
Aortic Stenosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with indication of TAVI followed in four french cardiology department.

Brief 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 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

Primary outcomes:
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score variation between the 2-months visit and inclusion.
timeFrame: Day 0 and Month 2
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Service de Cardiologie - CHU Clermont Ferrand
city: Lille
country: France
facility: Service de Cardiologie
city: Lyon
country: France
facility: Service de Cardiologie
city: Nantes
country: France
facility: Service de Cardiologie - Institut Thorax Nantes
Study officials:
References: