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Act on Quality of Life in Patients With aortIc Stenosis

Key facts

Who runs it
Hospices Civils de Lyon
Where
France4 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
240 people, planned
Started
19 Dec 2024
Expected to end
19 Dec 2027
Type of study
Observational, 2 groups
Treatments tested
  • Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score
Record updated
17 January 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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).

The 2 groups in the trial

  • 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.

    Treatment: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score

  • 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

    Treatment: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Act on Quality of Life in Poor Prognosis Aortic Stenosis Patients
Record updated
17 January 2025