Symptomatic Severe Aortic Valve Stenosis in Older PatientsTAVIQUALNCT01761357
Burden Comorbidities and Transcatheter Aortic Valve Implantation
A study testing answering to questionnaires of quality of live in people with Symptomatic Severe Aortic Valve Stenosis in Older Patients, run by Nantes University Hospital at 2 sites in France.
Trial summary
The aim of the study is to determine whether the burden of comorbidities measured by CIRS-G (Cumulative Illness Rate Scale) is associated with a non-amelioration of the health related quality of life measured by questionnaire called "SF-36", six months after a transcatheter aortic valve replacement in older patients. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Symptomatic Severe Aortic Valve Stenosis in Older Patients
- What is being tested?
- answering to questionnaires of quality of live
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2013to Dec 2014
- Phase
- Interventional
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 75 years and older
- Patients referred for a transcatheter aortic valve implantation
- Patients who have a comprehensive geriatric assessment realized during the three months before the valve implantation
- Patients who provide informed written consent
Who cannot join
- Patients who refuse the study
- Patients with a legal guardian
Trial locations and contacts
2 sites in 1 country.
France2 sites
Angers Universitary Hospital
Angers, 49933
Nantes Universitary Hospital
Nantes, 44093
About this study
Official title: Impact of Burden of Comorbidities on Health Related Quality of Life Six Months After Transcatheter Aortic Valve Implantation in Patients Aged 75 Years and Older.
The aim of the study is to determine whether the burden of comorbidities measured by CIRS-G (Cumulative Illness Rate Scale) is associated with a non-amelioration of the health related quality of life measured by questionnaire called "SF-36", six months after a transcatheter aortic valve replacement in older patients. During the comprehensive geriatric assessment realized before the valve implantation, the following data are recorded and their impact of the health related quality of life will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.
- Being tested
- answering to questionnaires of quality of live
- Keywords
- Aortic valve stenosis, Quality of life, Burden co morbidities, Transcatheter aortic valve implantation, Geriatric assessment
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
answering to questionnaires of quality of liveOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and one month after the valve implantation.
Measured: 1 month
Secondary outcomes (9)
Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and three months after the valve implantation.
Measured: three months
Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and six months after the valve implantation.
Measured: six months
Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and one month after the valve implantation.
Measured: one month
Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and three months after the valve implantation.
Measured: three months
Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and six months after the valve implantation.
Measured: six months
Difference of the score of the Geriatric Depression Scale (GDS), between inclusion and one month after the valve implantation.
Measured: one month
Difference of the score of the Geriatric Depression Scale called "GDS", between inclusion and three months after the valve implantation
Measured: three months
Difference of the score of the Geriatric Depression Scale scale called "GDS", between inclusion and six months after the valve implantation
Measured: six months
Complications during the six months of follow up with all causes of mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Severe Aortic Valve Stenosis in Older PatientsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761357
- Sponsor's protocol ID
- RC12_0387
- Acronym
- TAVIQUAL
- Status last verified
- Sep 2015
- First submitted
- 3 Jan 2013
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Boureau AS, Trochu JN, Rouaud A, Hureau R, Jaafar P, Manigold T, Letocart V, Guerin P, Berrut G, de Decker L. Predictors of Health-Related Quality of Life Decline after Transcatheter Aortic Valve Replacement in Older Patients with Severe Aortic Stenosis. J Nutr Health Aging. 2017;21(1):105-111. doi: 10.1007/s12603-016-0739-5.
PubMed 27999856
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Burden of Comorbidities on Health Related Quality of Life Six Months After Transcatheter Aortic Valve Implantation in Patients Aged 75 Years and Older.
- ClinicalTrials.gov ID
- NCT01761357
- Acronym / sponsor ID
- TAVIQUAL / RC12_0387
- Keywords
- Aortic valve stenosis, Quality of life, Burden co morbidities, Transcatheter aortic valve implantation, Geriatric assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Jan 2013 (estimated)
- 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.
The aim of the study is to determine whether the burden of comorbidities measured by CIRS-G (Cumulative Illness Rate Scale) is associated with a non-amelioration of the health related quality of life measured by questionnaire called "SF-36", six months after a transcatheter aortic valve replacement in older patients. During the comprehensive geriatric assessment realized before the valve implantation, the following data are recorded and their impact of the health related quality of life will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients aged 75 years and older
- Patients referred for a transcatheter aortic valve implantation
- Patients who have a comprehensive geriatric assessment realized during the three months before the valve implantation
- Patients who provide informed written consent
Key exclusion criteria (2 listed)
- Patients who refuse the study
- Patients with a legal guardian
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 |
|---|---|---|
| answering to questionnaires of quality of live | Other | – |
Primary outcome
Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and one month after the valve implantation.
Time frame: 1 month
9 secondary outcomes
Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and three months after the valve implantation.
Time frame: three months
Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and six months after the valve implantation.
Time frame: six months
Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and one month after the valve implantation.
Time frame: one month
Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and three months after the valve implantation.
Time frame: three months
Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and six months after the valve implantation.
Time frame: six months
Difference of the score of the Geriatric Depression Scale (GDS), between inclusion and one month after the valve implantation.
Time frame: one month
Difference of the score of the Geriatric Depression Scale called "GDS", between inclusion and three months after the valve implantation
Time frame: three months
Difference of the score of the Geriatric Depression Scale scale called "GDS", between inclusion and six months after the valve implantation
Time frame: six months
Complications during the six months of follow up with all causes of mortality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 27999856Boureau AS, Trochu JN, Rouaud A, Hureau R, Jaafar P, Manigold T, Letocart V, Guerin P, Berrut G, de Decker L. Predictors of Health-Related Quality of Life Decline after Transcatheter Aortic Valve Replacement in Older Patients with Severe Aortic Stenosis. J Nutr Health Aging. 2017;21(1):105-111. doi: 10.1007/s12603-016-0739-5.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing answering to questionnaires of quality of live in people with Symptomatic Severe Aortic Valve Stenosis in Older Patients, run by Nantes University Hospital at 2 sites 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and one month after the valve implantation. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01761357, which also lists 1 linked publication.
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 14 Sep 2026.