Clinical trial NCT01761357: Burden Comorbidities and Transcatheter Aortic Valve Implantation
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 150
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and one month after the valve implantation.
timeFrame: 1 month
Secondary outcomes:
measure: Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and three months after the valve implantation.
timeFrame: three months
measure: Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and six months after the valve implantation.
timeFrame: six months
measure: Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and one month after the valve implantation.
timeFrame: one month
measure: Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and three months after the valve implantation.
timeFrame: three months
measure: Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and six months after the valve implantation.
timeFrame: six months
measure: Difference of the score of the Geriatric Depression Scale (GDS), between inclusion and one month after the valve implantation.
timeFrame: one month
measure: Difference of the score of the Geriatric Depression Scale called "GDS", between inclusion and three months after the valve implantation
timeFrame: three months
measure: Difference of the score of the Geriatric Depression Scale scale called "GDS", between inclusion and six months after the valve implantation
timeFrame: six months
measure: Complications during the six months of follow up with all causes of mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers Universitary Hospital
city: Nantes
country: France
facility: Nantes Universitary Hospital
Study officials:
References: