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Burden Comorbidities and Transcatheter Aortic Valve Implantation (TAVIQUAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01761357
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Symptomatic Severe Aortic Valve Stenosis in Older Patients Other: answering to questionnaires of quality of live Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Difference of the score of the Geriatric Depression Scale (GDS), between inclusion and one month after the valve implantation. [ Time Frame: one month ]
  7. Difference of the score of the Geriatric Depression Scale called "GDS", between inclusion and three months after the valve implantation [ Time Frame: three months ]
  8. 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 ]
  9. Complications during the six months of follow up with all causes of mortality [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761357


Locations
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France
Angers Universitary Hospital
Angers, France, 49933
Nantes Universitary Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01761357    
Other Study ID Numbers: RC12_0387
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
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:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction