Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation
NCT ID: NCT04564534
Last Updated: 2022-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
109 participants
OBSERVATIONAL
2019-10-09
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study cohort
Adult (\>18 years) patients with aortic stenosis in whom TAVI is planned and who perform their pre-TAVI work-up in our centre will be invited to undergo cognitive assessment using the MoCA at the time of their hospitalization for pre-TAVI work-up.
The MoCA will be administered by trained professionals with MoCA certification.
Clinical outcomes, as assessed by the VARC2 criteria, will be collected for all patients at 3 months after the TAVI procedure.
MoCA cognitive assessment
cognitive assessment using the validated MoCA test administered via an application on an iPad
Interventions
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MoCA cognitive assessment
cognitive assessment using the validated MoCA test administered via an application on an iPad
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo TAVI
* Provide informed consent
* Able to understand French
Exclusion Criteria
* subjects with documented severe dementia
* subjects with anticipated poor compliance
* subjects unable to understand French sufficiently well to perform the MoCA test
* pregnant women
* subjects within the exclusion period of another study
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Francois Schiele, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHRU Besancon
Locations
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University Hospital Jean Minjoz
Besançon, , France
Countries
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Other Identifiers
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P/2019/417
Identifier Type: -
Identifier Source: org_study_id
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