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.

Nantes University Hospital2 sites in 1 country150 target enrollmentJanuary 2013

ConditionsSymptomatic Severe Aortic Valve Stenosis in Older Patients

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Symptomatic Severe Aortic Valve Stenosis in Older Patients
Sponsor: Nantes University Hospital
Enrollment: 150
Locations: 2
Primary Endpoint: Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and one month after the valve implantation.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

December 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nantes University Hospital

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)
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 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 Instrumental Activities of Daily Living scale called "IADL", between inclusion and one month after the valve implantation.(one month)
Complications during the six months of follow up with all causes of mortality(6 months)