Prospective Evaluation of the Quality of Life of Elderly Patients Undergoing Transfemoral Percutanous Aortic Valve Replacement (TAVI) for the Treatment of Severe Aortic Stenosis.

Prospective Evaluation of the Quality of Life of Elderly Patients Undergoing Transfemoral Percutanous Aortic Valve Replacement (TAVI) for the Treatment of Severe Aortic Stenosis. (TAVI QdV)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05539937

Acronym

TAVI QdV

Enrollment

140

Registered

2022-09-14

Start date

2023-03-21

Completion date

2026-03-31

Last updated

2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Replacement, Quality of Life, Transfemoral Approach

Brief summary

In order to overcome the shortcomings of the assessment questionnaires currently available on the assessment of overall quality of life, the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) was developed as a specific assessment tool for the impact of severe aortic stenosis in elderly patients, through 16 questions covering 5 domains: symptoms and physical limitations, emotional impact and expectations following TAVI, as well as social limitations incurred. A better knowledge and understanding of the clinical outcomes and quality of life of elderly patients with severe symptomatic aortic stenosis at 12 months of follow-up of a TAVI procedure would further optimize the clinical decision-making process and patient selection who will benefit the most from this intervention in the long term.

Interventions

OTHERQuality of life questionnaire

Before TAVI, 30 days, 6 months and twelve months after TAVI, patients will answer TASQ questionnaire,

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male, female, over 18 years old, * All patients who will have transfemoral percutaneous aortic valve replacement (TAVI) with implantation of a valve delivered on a balloon, * Patient able to understand the study, and answer the TASQ questionnaire, * Affiliation to a social security scheme or beneficiary of such a scheme, * Patient having signed the free and informed consent.

Exclusion criteria

* Minor, * Disorder of comprehension and/or expression, * Patients unable to answer questions due to an underlying cognitive deficit or physical disability, * Patients treated with a self-expanding valve, * Refusal to participate in the study, * Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision, * Pregnant, parturient, or breast-feeding patient.

Design outcomes

Primary

Measure	Time frame
Change in the TASQ global score 12 months after TAVI compared to the TASQ global score before TAVI	12 months

Countries

France

Contacts

Primary ContactMarie-Jeanne Bertrand, Dr

mariejeanne.bertrand@gmail.com04 38 38 04 34

Backup ContactJean-François Oudet

jeanfrancois.oudet@free.fr0683346567

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026