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Completed

NCT Number: NCT01761357

Burden Comorbidities and Transcatheter Aortic Valve Implantation

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.

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Key information

Conditions

Symptomatic Severe Aortic Valve Stenosis in Older Patients Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angers Universitary Hospital, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

answering to questionnaires of quality of live

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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.

Acronym: TAVIQUAL

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 4, 2013
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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