Actively Recruiting

Age: 18Years +
All Genders
NCT06477042

Act on Quality of Life in Patients With aortIc Stenosis

Led by Hospices Civils de Lyon · Updated on 2025-01-17

240

Participants Needed

4

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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of TAVIs equalled the number of surgeries by 2015, and TAVIs currently account for ¾ of aortic valve procedures (unpublished data).

CONDITIONS

Official Title

Act on Quality of Life in Patients With aortIc Stenosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with symptomatic aortic stenosis (exertional dyspnea, angina, malaise/syncope)
  • Indication for TAVI validated by Heart Team with valve area 1 cm8 or 1 cm8/m8 body surface area or mean transvalvular aortic gradient > 40 mmHg on ultrasound
  • Charlson score 65
  • Affiliation with social health care insurance
Not Eligible

You will not qualify if you...

  • 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 with an exclusion period still in progress
  • Persons under judicial protection
  • Patients under guardianship, curators or safeguard of justice

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

P

Pierre Lantelme, MD

CONTACT

J

Julia Canterini

CONTACT

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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