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

Completed

• Conditions: Cognitive Impairment; Older People--Abuse of; Aortic Stenosis, Severe

• Registration Number: NCT05813353
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-14
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Study First Posted: 2023-04-14
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Catharina Hospital; 🇳🇱 Eindhoven, Netherlands