Brief Title
Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation
Official Title
Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation
Brief Summary
This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI).
Detailed Description
This study plans to investigate the relationship between cognitive status pre-procedure, as assessed using the Montreal Cognitive Assessment (MoCA) administered on a tablet, and clinical outcomes at 3 months as assessed by the VARC2 criteria, in patients undergoing transcatheter aortic valve implantation (TAVI)
Study Type
Observational
Primary Outcome
All-cause death
Secondary Outcome
Time required for MoCA
Condition
Aortic Stenosis
Intervention
MoCA cognitive assessment
Study Arms / Comparison Groups
Study cohort
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
109
Start Date
October 9, 2019
Completion Date
September 30, 2021
Primary Completion Date
September 30, 2021
Eligibility Criteria
Inclusion Criteria: - Aged 18 years or over - Scheduled to undergo TAVI - Provide informed consent - Able to understand French Exclusion Criteria: - subjects under legal guardianship or other legal protection - 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Francois Schiele, MD, PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04564534
Organization ID
P/2019/417
Responsible Party
Sponsor
Study Sponsor
Centre Hospitalier Universitaire de Besancon
Study Sponsor
Francois Schiele, MD, PhD, Principal Investigator, CHRU Besancon
Verification Date
February 2022