Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation

Withdrawn

• Conditions: Aortic Stenosis
• Interventions: Other: Neuropsychological testing

• Registration Number: NCT01648309
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-24
• Study Start: 2012-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAVI	Neuropsychological testing	patients with significant aortic stenosis that are candidates for transvascular aortic valve implantation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel