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

NCT ID: NCT05813353

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-14

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role lead

Responsible Party

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Mariska te Pas

Drs. Mariska te Pas

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catharina Hospital

Eindhoven, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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nWMO-2020.106

Identifier Type: -

Identifier Source: org_study_id

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