search
Back to results

Burden Comorbidities and Transcatheter Aortic Valve Implantation (TAVIQUAL)

Primary Purpose

Symptomatic Severe Aortic Valve Stenosis in Older Patients

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
answering to questionnaires of quality of live
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Symptomatic Severe Aortic Valve Stenosis in Older Patients focused on measuring Aortic valve stenosis, Quality of life, Burden co morbidities, Transcatheter aortic valve implantation, Geriatric assessment

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Angers Universitary Hospital
  • Nantes Universitary Hospital

Outcomes

Primary Outcome Measures

Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and one month after the valve implantation.

Secondary Outcome Measures

Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and three months after the valve implantation.
Difference of the physical component summary score of the health survey scale called "SF36", between inclusion and six months after the valve implantation.
Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and one month after the valve implantation.
Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and three months after the valve implantation.
Difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between inclusion and six months after the valve implantation.
Difference of the score of the Geriatric Depression Scale (GDS), between inclusion and one month after the valve implantation.
Difference of the score of the Geriatric Depression Scale called "GDS", between inclusion and three months after the valve implantation
Difference of the score of the Geriatric Depression Scale scale called "GDS", between inclusion and six months after the valve implantation
Complications during the six months of follow up with all causes of mortality

Full Information

First Posted
January 3, 2013
Last Updated
September 22, 2015
Sponsor
Nantes University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01761357
Brief Title
Burden Comorbidities and Transcatheter Aortic Valve Implantation
Acronym
TAVIQUAL
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Severe Aortic Valve Stenosis in Older Patients
Keywords
Aortic valve stenosis, Quality of life, Burden co morbidities, Transcatheter aortic valve implantation, Geriatric assessment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
answering to questionnaires of quality of live
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Difference of the score of the Geriatric Depression Scale (GDS), between inclusion and one month after the valve implantation.
Time Frame
one month
Title
Difference of the score of the Geriatric Depression Scale called "GDS", between inclusion and three months after the valve implantation
Time Frame
three months
Title
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
Title
Complications during the six months of follow up with all causes of mortality
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Angers Universitary Hospital
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Nantes Universitary Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Learn more about this trial

Burden Comorbidities and Transcatheter Aortic Valve Implantation

We'll reach out to this number within 24 hrs