Burden Comorbidities and Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Symptomatic Severe Aortic Valve Stenosis in Older Patients

Intervention / Treatment
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* Other: answering to questionnaires of quality of live


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: answering to questionnaires of quality of live|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time 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 implantation |  | three months | 
| Difference of the score of the Geriatric Depression Scale scale called GDS, between inclusion and six months after the valve implantation |  | six months | 
| Complications during the six months of follow up with all causes of mortality |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic valve stenosis, Quality of life, Burden co morbidities, Transcatheter aortic valve implantation, Geriatric assessment