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

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

Completed

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Key information

Conditions

Cognitive Impairment Aortic Stenosis, Severe Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Heart Diseases Heart Valve Diseases Mental Disorders Neurocognitive Disorders Older People--Abuse of Ventricular Outflow Obstruction

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina Hospital

Eindhoven, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Usability of BAMCOG

Time frame: 3 months preoperative
Concurrent validation of BAMCOG with MoCA

Time frame: 3 months preoperative - 3 months postoperative
Cerebral perfusion/carotid flow measurements

Time frame: Peroperative

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Apr 14, 2023
Registry last updated: Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed