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Burden Comorbidities and Transcatheter Aortic Valve Implantation

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01761357
Acronym
TAVIQUAL
Enrollment
150
Registered
2013-01-04
Start date
2013-01-01
Completion date
2014-12-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Severe Aortic Valve Stenosis in Older Patients

Keywords

Aortic valve stenosis, Quality of life, Burden co morbidities, Transcatheter aortic valve implantation, Geriatric assessment

Brief 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. 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.

Interventions

OTHERanswering to questionnaires of quality of live

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patients who refuse the study * Patients with a legal guardian

Design outcomes

Primary

MeasureTime frame
Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and one month after the valve implantation.1 month

Secondary

MeasureTime frame
Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and three months after the valve implantation.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.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.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.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.six months
Difference of the score of the Geriatric Depression Scale (GDS), between inclusion and one month after the valve implantation.one month
Difference of the score of the Geriatric Depression Scale called "GDS", between inclusion and three months after the valve implantationthree months
Difference of the score of the Geriatric Depression Scale scale called "GDS", between inclusion and six months after the valve implantationsix months
Complications during the six months of follow up with all causes of mortality6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026