Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation

Neuropsychological Testing in Patients Undergoing TAVI

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01648309

Acronym

TAVIPSYCH

Enrollment

Registered

2012-07-24

Start date

2012-09-30

Completion date

2014-09-30

Last updated

2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Keywords

aortic stenosis, TAVI, neuropsychological, cognitive, candidates for TAVI

Brief summary

The purpose of this study is to examine the neuropsychological effects of transvascular aortic valve implantation (TAVI). Patients undergoing TAVI usually suffer from congestive heart failure and low cardiac output which may limit their cognitive abilities. TAVI results in significant improvements in cardiac function and therefore may improve cognitive functions. However, TAVI may also be associated with stroke and may therefore have a negative impact on cognition. Therefore, in this study the investigators wish to perform a battery of standardized neuropsychological tests before and after TAVI to test the net effects of TAVI on cognitive performance over time. The investigators plan to include all patients planned to have TAVI in the study and to test them before, 3,7, 30 and 360 days post TAVI with a standardized battery of test.

Interventions

OTHERNeuropsychological testing

This is an observational study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

* All patients with severe aortic stenosis that are candidates for TAVI * Able to perform the testing * Able to sign informed consent

Exclusion criteria

* Language barriers precluding the administration of the testing * Existing dementia * Existing disease limiting life expectancy to less than 180 days

Design outcomes

Primary

Measure	Time frame	Description
net change in neuropsychological tests between baseline and day 180 from TAVI	180 days	The study will assess changes in cognitive performance between baseline (prior to TAVI) and 180 days after TAVI

Secondary

Measure	Time frame	Description
net difference between cognitive measures before TAVI and at day 30 after TAVI	30 days	The study will evaluate net differences between scores obtained on cognitive tests at baseline prior to TAVI and day 30 after TAVI

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026