Burden Comorbidities and Transcatheter Aortic Valve Implantation

Nantes University Hospital150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

150

Conditions

Symptomatic Severe Aortic Valve Stenosis in Older Patients

Interventions

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Angers Universitary Hospital

Angers, France

Nantes Universitary Hospital

Nantes, France

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 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