Pre- and Post TAVI Cognitive Functioning and Intraoperative Carotid Flow Measurements

Usability Study of the BAMCOG Followed by Concurrent Validation of the BAMCOG With the MoCA as a Monitoring Instrument for Perioperative Cognitive Function

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05813353

Enrollment

Registered

2023-04-14

Start date

2021-07-14

Completion date

2022-12-31

Last updated

2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Severe, Cognitive Impairment, Older People--Abuse of

Brief summary

Purpose: 1. Measuring and optimize the usability of the BAMCOG (games to measure cognitive functioning) 2. Concurrent validation of BAMCOG with MoCA to see if BAMCOG can serve as a monitoring instrument/screener 3. Determination of carotid flow/cerebral blood flow pre- and post implant of prosthesis of aortic valve by ultrasound doppler measurements

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* \> 65 years old * Scheduled for TAVI surgery * Able to play games on a tablet * For usability part \> MoCA score of 26 or higher * Near native dutch speaker

Exclusion criteria

* Mental disorder (unable to play games) * Alcohol abuse (women \<15 and men \>22 alcoholic drinks/week) * No informed consent * Atrial fibrillitation (for ultrasound doppler)

Design outcomes

Primary

Measure	Time frame
Usability of BAMCOG	3 months preoperative
Concurrent validation of BAMCOG with MoCA	3 months preoperative - 3 months postoperative
Cerebral perfusion/carotid flow measurements	Peroperative

Countries

Netherlands

Outcome results