Burden Comorbidities and Transcatheter Aortic Valve Implantation (TAVIQUAL)

This study is currently recruiting participants.
Verified September 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01761357
First received: January 3, 2013
Last updated: September 24, 2013
Last verified: September 2013

January 3, 2013
September 24, 2013
January 2013
February 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
to determine the difference of the physical component summary score of the health survey scale called "SF36", between the inclusion and one month after the valve implantation. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01761357 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Difference of the score of the Geriatric Depression Scale (GDS), between inclusion and one month after the valve implantation. [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Difference of the score of the Geriatric Depression Scale called "GDS", between inclusion and three months after the valve implantation [ Time Frame: three months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Complications during the six months of follow up with all causes of mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • to determine the difference of the physical component summary score of the health survey scale called "SF36", between the inclusion and three months after the valve implantation. [ Time Frame: three months ] [ Designated as safety issue: No ]
  • to determine the difference of the physical component summary score of the health survey scale called "SF36", between the inclusion and six months after the valve implantation. [ Time Frame: six months ] [ Designated as safety issue: No ]
  • to determine the difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between the inclusion and one month after the valve implantation. [ Time Frame: one month ] [ Designated as safety issue: No ]
  • to determine the difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between the inclusion and three months after the valve implantation. [ Time Frame: three months ] [ Designated as safety issue: No ]
  • to determine the difference of the score of the Instrumental Activities of Daily Living scale called "IADL", between the inclusion and six months after the valve implantation. [ Time Frame: six months ] [ Designated as safety issue: No ]
  • to determine the difference of the score of the Geriatric Depression Scale (GDS), between the inclusion and one month after the valve implantation. [ Time Frame: one month ] [ Designated as safety issue: No ]
  • to determine the difference of the score of the Geriatric Depression Scale called "GDS", between the inclusion and three months after the valve implantation [ Time Frame: three months ] [ Designated as safety issue: No ]
  • to determine the difference of the score of the Geriatric Depression Scale scale called "GDS", between the inclusion and six months after the valve implantation [ Time Frame: six months ] [ Designated as safety issue: No ]
  • Complications during the six months of follow up with all causes of mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Burden Comorbidities and Transcatheter Aortic Valve Implantation
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.

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Symptomatic Severe Aortic Valve Stenosis in Older Patients
Other: answering to questionnaires of quality of live
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
July 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
75 Years and older
No
Contact: Jean Noel TROCHU, PU-PH : +33 2 40 16 52 77 jeannoel.trochu@chu-nantes.fr
Contact: Laure De Decker, PH laure.dedecker@chu-nantes.fr
France
 
NCT01761357
RC12_0387
No
Nantes University Hospital
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP