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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-21

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI

NCT03186339

Aortic Valve Stenosis

COMPLETED

Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement

NCT05261204

Prosthesis Survival Prosthesis; Cardiac, Heart, Functional Disturbance as Result

ENROLLING_BY_INVITATION

Future Optimal Research and Care Evaluation - Aortic Stenosis

NCT06168123

Severe Aortic Valve Stenosis Moderate Aortic Valve Stenosis

RECRUITING

A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis

NCT07108478

Severe Aortic Valve Stenosis

NOT_YET_RECRUITING

Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.

NCT05886517

Aortic Stenosis

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Quality of Life Aortic Valve Replacement Transfemoral Approach

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient with percutaneous aortic valve replacement via the transfemoral approach

Quality of life questionnaire

Intervention Type OTHER

Before TAVI, 30 days, 6 months and twelve months after TAVI, patients will answer TASQ questionnaire,

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quality of life questionnaire

Before TAVI, 30 days, 6 months and twelve months after TAVI, patients will answer TASQ questionnaire,

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No