Evaluating quality of life in elderly patients after aortic valve replacement
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)
Elsan · NCT05539937
This study is trying to see how getting a new heart valve through a less invasive procedure affects the quality of life for older patients over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elsan (other) |
| Locations | 1 site (La Rochette) |
| Trial ID | NCT05539937 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the quality of life of elderly patients undergoing transfemoral percutaneous aortic valve replacement (TAVI) for severe aortic stenosis. It utilizes the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ), which includes 16 questions across five domains to evaluate symptoms, emotional impact, and social limitations. The study will follow patients for 12 months post-procedure to gather insights on clinical outcomes and optimize patient selection for TAVI. The findings are expected to enhance understanding of how TAVI affects the quality of life in this demographic.
Who should consider this trial
Good fit: Ideal candidates include elderly patients over 18 years old who are scheduled for transfemoral TAVI and can comprehend and respond to the TASQ questionnaire.
Not a fit: Patients who are minors, have cognitive deficits, or are unable to participate due to physical disabilities will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection and better clinical outcomes for elderly patients undergoing TAVI.
How similar studies have performed: Other studies have successfully utilized quality of life assessments in similar patient populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Rochette
- Jean-François Oudet — La Rochette, France (RECRUITING)
Study contacts
- Study coordinator: Marie-Jeanne Bertrand, Dr
- Email: mariejeanne.bertrand@gmail.com
- Phone: 04 38 38 04 34
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Quality of Life, Aortic Valve Replacement, Transfemoral Approach