Pre- and Post TAVI Cognitive Functioning and Intraoperati... | NCT05813353

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

NCT05813353

Sponsor

Catharina Ziekenhuis Eindhoven

Status

Completed

Last Update Posted

Apr 14, 2023Actual

Enrollment

54Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 14, 2021Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Apr 3, 2023

First Submission Date that Met QC Criteria

Apr 3, 2023

First Posted Date

Apr 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2023

Last Update Posted Date

Apr 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Purpose:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Elderly patients undergoing TAVI surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catharina Hospital		Eindhoven			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D000082862	Aortic Valve Disease

Browse Leaves

Not provided

Browse Branches

Not provided