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

Quality of Life Clinical Trial

— TAVI QdV  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05539937
• Other study ID #: 2022-A00820-43
• Status: Recruiting
• Start date: March 21, 2023
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: Elsan
• Contact: Marie-Jeanne Bertrand, Dr
• Phone: 04 38 38 04 34
• Email: mariejeanne.bertrand[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Replacement
• Aortic Valve Stenosis
• Quality of Life

Intervention

Other:
• Quality of life questionnaire
Before TAVI, 30 days, 6 months and twelve months after TAVI, patients will answer TASQ questionnaire,

Locations

Country	Name	City	State
France	Jean-François Oudet	La Rochette

Sponsors (3)

Lead Sponsor	Collaborator
Elsan	Belledonne clinic, European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the TASQ global score 12 months after TAVI compared to the TASQ global score before TAVI		12 months