Burden Comorbidities and Transcatheter Aortic Valve Implantation (TAVIQUAL)

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Symptomatic Severe Aortic Valve Stenosis in Older Patients
Other: answering to questionnaires of quality of live

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

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. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

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. [ 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 ]

Estimated Enrollment: 160
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761357

Contacts
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

Locations
France
Angers Universitary Hospital Recruiting
Angers, France, 49933
Contact: Fabrice Prunier, PU-PH       FaPrunier@chu-angers.fr   
Contact: Raphaelle Hureaux-Huynh, PH       RaHureaux@chu-angers.fr   
Principal Investigator: Fabrice Prunier, PU-PH         
Sub-Investigator: Raphaelle Hureaux-Huynh, PH         
Nantes Universitary Hospital Recruiting
Nantes, France, 44093
Contact: Jean-noel Trochu, PU-PH    +33 2 40 16 52 77    jeannoel.trochu@chu-nantes.fr   
Contact: Laure de Decker, PH    +33 2 40 06 50 46    laure.dedecker@chu-nantes.fr   
Sub-Investigator: Laure De Decker, PH         
Principal Investigator: Jean-noel Trochu, PU-PH         
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01761357     History of Changes
Other Study ID Numbers: RC12_0387
Study First Received: January 3, 2013
Last Updated: September 24, 2013
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Nantes University Hospital:
Aortic valve stenosis
Quality of life
Burden co morbidities
Transcatheter aortic valve implantation
Geriatric assessment

Additional relevant MeSH terms:
Aortic Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on October 23, 2014