Burden Comorbidities and Transcatheter Aortic Valve Implantation (TAVIQUAL)

September 22, 2015 updated by: Nantes University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Angers Universitary Hospital
      • Nantes, France, 44093
        • Nantes Universitary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: six months
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.
Time Frame: one month
one month
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
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.
Time Frame: six months
six months
Difference of the score of the Geriatric Depression Scale (GDS), between inclusion and one month after the valve implantation.
Time Frame: one month
one month
Difference of the score of the Geriatric Depression Scale called "GDS", between inclusion and three months after the valve implantation
Time Frame: three months
three months
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
six months
Complications during the six months of follow up with all causes of mortality
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

January 3, 2013

First Posted (Estimate)

January 4, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC12_0387

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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