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

Recruiting

• Conditions: Transfemoral Approach; Quality of Life; Aortic Valve Replacement
• Interventions: Other: Quality of life questionnaire

• Registration Number: NCT05539937
• Lead Sponsor: Elsan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-14
• Study Start: 2023-03-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with percutaneous aortic valve replacement via the transfemoral approach	Quality of life questionnaire	-

Primary Outcome Measures

Name	Time	Method
Change in the TASQ global score 12 months after TAVI compared to the TASQ global score before TAVI	12 months

Trial Locations

Locations (1)

Jean-François Oudet; 🇫🇷 La Rochette, France