Burden Comorbidities and Transcatheter Aortic Valve Implantation (TAVIQUAL)
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ClinicalTrials.gov Identifier: NCT01761357 |
Recruitment Status :
Completed
First Posted : January 4, 2013
Last Update Posted : September 23, 2015
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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 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 |

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

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Ages Eligible for Study: | 75 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
France | |
Angers Universitary Hospital | |
Angers, France, 49933 | |
Nantes Universitary Hospital | |
Nantes, France, 44093 |
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 |
Aortic valve stenosis Quality of life Burden co morbidities Transcatheter aortic valve implantation Geriatric assessment |
Aortic Valve Stenosis Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |