Burden Comorbidities and Transcatheter Aortic Valve Implantation

Not Applicable

Completed

• Conditions: Symptomatic Severe Aortic Valve Stenosis in Older Patients

• Registration Number: NCT01761357
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Angers Universitary Hospital; 🇫🇷 Angers, France

Nantes Universitary Hospital; 🇫🇷 Nantes, France