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

Launched by ELSAN · Sep 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how undergoing a specific heart procedure called Transfemoral Aortic Valve Replacement (TAVI) affects the quality of life for elderly patients suffering from severe aortic stenosis, a condition where the heart's aortic valve becomes narrowed and can cause serious health issues. Researchers have created a special questionnaire called the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) to gather information on various aspects of patients' lives, including their symptoms, emotional well-being, and social interactions, over a year after the procedure.

To participate in this trial, you need to be at least 18 years old and scheduled to have the TAVI procedure with a specific type of valve. You should also be able to understand the study and answer the TASQ questionnaire. Unfortunately, individuals under 18, those with certain cognitive or physical difficulties that prevent them from answering questions, and people who are pregnant or under legal protection cannot take part. If you join the study, you can expect to share your experiences through the TASQ to help researchers better understand how this treatment impacts the lives of elderly patients in the long run.

Gender

ALL

Eligibility criteria

• 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.