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

Sponsor
Elsan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05539937
Collaborator
Belledonne clinic (Other), European Clinical Trial Experts Network (Other)
140
1
24
5.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Quality of life questionnaire

Study Design

Study Type:
Observational
Anticipated Enrollment :
140 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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)
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Patient with percutaneous aortic valve replacement via the transfemoral approach

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

Outcome Measures

Primary Outcome Measures

  1. Change in the TASQ global score 12 months after TAVI compared to the TASQ global score before TAVI [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jean-Fran├žois Oudet La Rochette France 77000

Sponsors and Collaborators

  • Elsan
  • Belledonne clinic
  • European Clinical Trial Experts Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elsan
ClinicalTrials.gov Identifier:
NCT05539937
Other Study ID Numbers:
  • 2022-A00820-43
First Posted:
Sep 14, 2022
Last Update Posted:
Sep 14, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2022