Quality of LifeTAVI QdVNCT05539937
Prospective Evaluation of the Quality of Life of Elderly Patients Undergoing Transfemoral Percutanous Aortic Valve Replacement (TAVI) for the Treatment of Severe Aortic Stenosis.
An observational study of Quality of Life and Aortic Valve Replacement, run by Elsan at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Aortic Valve Replacement, Transfemoral Approach
- What is being tested?
- Quality of life questionnaire
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2023to Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who will have benefited of a transfemoral percutaneous aortic valve replacement; male or femal over 18 years of age.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Jean-François Oudet
La Rochette, 77000
Jean-François Oudet, jeanfrancois.oudet@free.fr
About this study
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)
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.
- Being tested
- Quality of life questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnaireOther
Before TAVI, 30 days, 6 months and twelve months after TAVI, patients will answer TASQ questionnaire,
| Study group | Role | What they receive |
|---|---|---|
| Patient with percutaneous aortic valve replacement via the transfemoral approach | Not described Receives: Other: Quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the TASQ global score 12 months after TAVI compared to the TASQ global score before TAVI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start21 Mar 2023
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Collaborators
- Belledonne clinic, European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539937
- Sponsor's protocol ID
- 2022-A00820-43
- Acronym
- TAVI QdV
- Status last verified
- Apr 2024
- First submitted
- 12 Sep 2022
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05539937
- Acronym / sponsor ID
- TAVI QdV / 2022-A00820-43
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Collaborators
- Belledonne clinic, European Clinical Trial Experts Network
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with percutaneous aortic valve replacement via the transfemoral approach | – | Other: Quality of life questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who will have benefited of a transfemoral percutaneous aortic valve replacement; male or femal over 18 years of age.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life questionnaireBefore TAVI, 30 days, 6 months and twelve months after TAVI, patients will answer TASQ questionnaire, | Other | Patient with percutaneous aortic valve replacement via the transfemoral approach |
Primary outcome
Change in the TASQ global score 12 months after TAVI compared to the TASQ global score before TAVI
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Aortic Valve Replacement, run by Elsan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Jeanne Bertrand, Dr (04 38 38 04 34, mariejeanne.bertrand@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the TASQ global score 12 months after TAVI compared to the TASQ global score before TAVI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.