Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation

Aortic Stenosis Clinical Trial

— TAVIPSYCH  

Official title:

Neuropsychological Testing in Patients Undergoing TAVI

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01648309
• Other study ID #: TAVIPSYCH-HMO-CTIL
• Secondary ID: TAVI registry Ha
• Status: Withdrawn
• Phase: N/A
• First received: July 16, 2012
• Last updated: August 15, 2016
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: August 2016
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel:Ministry of Health - Director General
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Other:
• Neuropsychological testing
This is an observational study

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	net change in neuropsychological tests between baseline and day 180 from TAVI	The study will assess changes in cognitive performance between baseline (prior to TAVI) and 180 days after TAVI	180 days	No
Secondary	net difference between cognitive measures before TAVI and at day 30 after TAVI	The study will evaluate net differences between scores obtained on cognitive tests at baseline prior to TAVI and day 30 after TAVI	30 days	No