NCT05813353

Brief Summary

Purpose:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

April 3, 2023

Last Update Submit

April 3, 2023

Conditions

Cognitive ImpairmentOlder People--Abuse ofAortic Stenosis, Severe

Outcome Measures

Primary Outcomes (3)

  • Usability of BAMCOG

    3 months preoperative

  • Concurrent validation of BAMCOG with MoCA

    3 months preoperative - 3 months postoperative

  • Cerebral perfusion/carotid flow measurements

    Peroperative

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly patients undergoing TAVI surgery

You may qualify if:

  • \> 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina Hospital

Eindhoven, Netherlands

Location

MeSH Terms

Conditions

Cognitive DysfunctionAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersAortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Drs. Mariska te Pas

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 14, 2023

Study Start

July 14, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 14, 2023

Record last verified: 2023-04

Locations

NL(1)