Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation (TAVI-Geriatrie)

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Aortic Stenosis

Treatments: Other: MoCA cognitive assessment

Study type: Observational

Funder types: Other

Identifiers

NCT04564534

P/2019/417

Details and patient eligibility

About

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).

Full 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)

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

109 participants in 1 patient group

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.

Treatment:

Other: MoCA cognitive assessment